[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 2209 Introduced in Senate (IS)]
<DOC>
117th CONGRESS
1st Session
S. 2209
To amend the Federal Food, Drug, and Cosmetic Act to provide for the
regulation of in vitro clinical tests, and for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
June 24, 2021
Mr. Burr (for himself and Mr. Bennet) introduced the following bill;
which was read twice and referred to the Committee on Health,
Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to provide for the
regulation of in vitro clinical tests, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Verifying Accurate
Leading-edge IVCT Development Act of 2021'' or the ``VALID Act of
2021''.
(b) Table of Contents.--The table of contents of this Act is as
follows:
Sec. 1. Short title; table of contents.
Sec. 2. Definitions.
Sec. 3. Regulation of in vitro clinical tests.
``subchapter j--in vitro clinical tests
``Sec. 587. Definitions.
``Sec. 587A. Applicability.
``Sec. 587B. Premarket review.
``Sec. 587C. Breakthrough in vitro clinical tests.
``Sec. 587D. Technology certification.
``Sec. 587E. Mitigating measures.
``Sec. 587F. Regulatory pathway redesignation.
``Sec. 587G. Advisory committees.
``Sec. 587H. Request for informal feedback.
``Sec. 587I. Registration and listing.
``Sec. 587J. Test design and quality requirements.
``Sec. 587K. Labeling requirements.
``Sec. 587L. Adverse event reporting.
``Sec. 587M. Corrections and removals.
``Sec. 587N. Restricted in vitro clinical tests.
``Sec. 587O. Appeals.
``Sec. 587P. Accredited persons.
``Sec. 587Q. Recognized standards.
``Sec. 587R. Investigational use.
``Sec. 587S. Collaborative communities for in vitro clinical
tests.
``Sec. 587T. Comprehensive test information system.
``Sec. 587U. Preemption.
``Sec. 587V. Adulteration.
``Sec. 587W. Misbranding.
``Sec. 587X. Postmarket surveillance.
``Sec. 587Y. Electronic format for submissions.
``Sec. 587Z. Postmarket remedies.
Sec. 4. Enforcement and other provisions.
Sec. 5. Transition.
Sec. 6. Emergency use authorization.
Sec. 7. Antimicrobial susceptibility tests.
Sec. 8. Combination products.
Sec. 9. Resources.
SEC. 2. DEFINITIONS.
(a) In General.--Section 201 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321) is amended--
(1) by adding at the end the following:
``(ss)(1) The term `in vitro clinical test'--
``(A) means a test intended by its developer (as defined in
section 587) to be used in the collection, preparation,
analysis, or in vitro clinical examination of specimens taken
or derived from the human body for the purpose of--
``(i) identifying or diagnosing a disease or
condition;
``(ii) providing information for diagnosing,
screening, measuring, detecting, predicting,
prognosing, analyzing, or monitoring a disease or
condition, including by making a determination of an
individual's state of health; or
``(iii) selecting, monitoring, or informing therapy
or treatment for a disease or condition; and
``(B) may include--
``(i) a test protocol or laboratory test protocol;
``(ii) an instrument (as defined in section
587(11));
``(iii) a specimen receptacle;
``(iv) software, excluding software that is
excluded by section 520(o) from the definition of a
device under section 201(h), and excluding
modifications that are exempt in accordance with
section 587A(l)(2)(A); and
``(v) subject to subparagraph (2), a component or
part of a test, a test protocol, an instrument, an
article, or software described in any of clauses (A)
through (D) of such subparagraph, whether alone or in
combination, including reagents, calibrators, and
controls.
``(2) Notwithstanding subparagraph (1)(v), an article intended to
be used as a component or part of an in vitro clinical test described
in subparagraph (1) is excluded from the definition in subparagraph (1)
if the article consists of any of the following:
``(A) Blood, blood components, or human cells or tissues,
from the time of acquisition, donation, or recovery of such
article, including determination of donor eligibility, as
applicable, until such time as the article is released as a
component or part of an in vitro clinical test by the
establishment that collected such article.
``(B) An article used for invasive sampling, a needle, or a
lancet, except to the extent such article, needle, or lancet is
an integral component of an article for holding, storing, or
transporting a specimen.
``(C) General purpose laboratory equipment, including
certain pre-analytical equipment, as determined by the
Secretary.
``(D) An article used solely for personal protection during
the administering, conducting, or otherwise performing of test
activities.'';
(2) by adding at the end of section 201(g) the following:
``(3) The term `drug' does not include an in vitro clinical
test.''; and
(3) in section 201(h), by striking ``section 520(o)'' and
inserting ``section 520(o) or an in vitro clinical test''.
(b) Exclusion From Definition of Biological Product.--Section
351(i)(1) of the Public Health Service Act (42 U.S.C. 262(i)(1)) is
amended--
(1) by striking ``(1) The term `biological product' means''
and inserting ``(1)(A) The term `biological product' means'';
and
(2) by adding at the end the following:
``(B) The term `biological product' does not include an in
vitro clinical test as defined in section 201(ss) of the
Federal Food, Drug, and Cosmetic Act.''.
(c) In Vitro Clinical Test Definition.--In this Act, the term ``in
vitro clinical test'' has the meaning given such term in section
201(ss) of the Federal Food, Drug, and Cosmetic Act, as added by
subsection (a).
SEC. 3. REGULATION OF IN VITRO CLINICAL TESTS.
The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) is
amended--
(1) by amending the heading of chapter V to read as
follows: ``DRUGS, DEVICES, AND IN VITRO CLINICAL TESTS''; and
(2) by adding at the end of chapter V the following:
``Subchapter J--In Vitro Clinical Tests
``SEC. 587. DEFINITIONS.
``In this subchapter:
``(1) Analytical validity.--
``(A) The term `analytical validity' means, with
respect to an in vitro clinical test, the ability of
the in vitro clinical test, to--
``(i) sufficiently identify, measure,
detect, calculate, or analyze one or more
analytes, biomarkers, substances, or other
targets intended to be identified, measured,
detected, calculated, or analyzed by the test;
or
``(ii) as applicable, assist in such
identification, measurement, detection,
calculation, or analysis.
``(B) For an article for taking or deriving
specimens from the human body described in section
201(ss)(1)(B)(iii), the term `analytical validity'
means that such article performs as intended and will
support the analytical validity of an in vitro clinical
test with which it is used.
``(2) Applicable standard.--The term `applicable standard',
with respect to an in vitro clinical test, means a reasonable
assurance of analytical and clinical validity, except that such
term--
``(A) with respect to test instruments, means a
reasonable assurance of analytical validity; and
``(B) with respect to articles for taking or
deriving specimens from the human body for purposes
described in clause (i) or (ii) of section
201(ss)(1)(A) means a reasonable assurance of
analytical validity and, where applicable, safety.
``(3) Clinical use.--The term `clinical use' means the
operation, application, or functioning of an in vitro clinical
test in connection with human specimens, including patient,
consumer, and donor specimens, for the purpose for which it is
intended as described in section 201(ss)(1)(A).
``(4) Clinical validity.--The term `clinical validity'
means the ability of an in vitro clinical test to achieve the
purpose for which it is intended as described in section
201(ss)(1)(A).
``(5) Cross-referenced test.--The term `cross-referenced
test' means an in vitro clinical test that references in its
labeling the name or intended use of another medical product
that is not an in vitro clinical test.
``(6) Develop.--The term `develop', with respect to an in
vitro clinical test, means--
``(A) designing, validating, producing,
manufacturing, remanufacturing, propagating, or
assembling an in vitro clinical test;
``(B) importing an in vitro clinical test;
``(C) modifying an in vitro clinical test initially
developed by a different person in a manner that--
``(i) changes any of the listing elements
that define indications for use specified in
paragraph (10), performance claims, or, as
applicable, the safety of such in vitro
clinical test; or
``(ii) affects the analytical or clinical
validity of the in vitro clinical test as
intended by the developer; or
``(D) adopting, using, or disseminating for use as
an in vitro clinical test an article not previously
intended for clinical use.
``(7) Developer.--The term `developer' means a person who
engages in an activity described in paragraph (6) for clinical
use.
``(8) First-of-a-kind.--The term `first-of-a-kind' means,
with respect to an in vitro clinical test, a test that has an
intended use and a combination of the elements specified in
paragraph (10) that differ from the intended use and such
elements of other in vitro clinical tests that already are
legally available in the United States.
``(9) High-risk.--
``(A) In general.--Subject to subparagraph (B), the
term `high-risk', with respect to an in vitro clinical
test or category of in vitro clinical tests--
``(i) means that, when used as intended by
the developer, an undetected inaccurate result
from such test or category--
``(I) presents unreasonable risk
for serious or irreversible harm or
death to a patient or patients, or
would otherwise cause serious harm to
the public health; or
``(II) is potentially likely to
result in the absence, significant
delay, or discontinuation of life-
supporting or life-sustaining medical
treatment; and
``(ii) shall account for the degree to
which the technology for the intended use of an
in vitro clinical test or tests is well-
characterized and the criteria for performance
of the test or tests are well-established for
the intended use, the clinical circumstances
under which the in vitro clinical test is used,
and the availability of other tests (such as
confirmatory or adjunctive tests).
``(B) Exception.--The term `high-risk' does not
include an in vitro clinical test described in
subparagraph (A) if--
``(i) mitigating measures are established
to prevent, detect, or otherwise mitigate the
risk of inaccurate results as described in
subparagraph (A), or
``(ii) an exemption from the definition of
such term applies under section 587A.
``(10) Indications for use.--The term `indications for use'
means one or more in vitro clinical tests that have all of the
following notification elements in common:
``(A) Substance or substances measured by the in
vitro clinical test, such as an analyte, protein, or
pathogen.
``(B) Test method.
``(C) Test purpose or purposes, as described in
section 201(ss)(1)(A).
``(D) Diseases or conditions for which the in vitro
clinical test is intended for use, including intended
patient populations.
``(E) Context of use, such as in a clinical
laboratory, in a health care facility, prescription
home use, over-the-counter use, or direct-to-consumer
testing.
``(11) Instrument.--The term `instrument' means an in vitro
clinical test that is hardware intended by the hardware's
developer to be used with one or more in vitro clinical tests
to generate a clinical test result, including software used to
effectuate the hardware's functionality.
``(12) Instrument family.--The term `instrument family'
means more than one instrument for which the developer
demonstrates and documents, with respect to all such
instruments, that all--
``(A) have the same basic architecture, design, and
performance characteristics, such as tolerance limits
and signal range;
``(B) have the same intended use or uses and
function;
``(C) share the same measurement principles,
detection methods, and reaction conditions; and
``(D) produce the same or similar analytical
results from samples of the same specimen type or
types.
``(13) Laboratory operations.--The term `laboratory
operations'--
``(A) means the conduct of a laboratory examination
or other laboratory procedure on materials derived from
the human body, including the conduct of an in vitro
clinical test and associated activities within or under
the oversight of a laboratory and not related to the
design of an in vitro clinical test; and
``(B) includes--
``(i) performing pre-analytical and post-
analytical processes for an in vitro clinical
test;
``(ii) conducting standard operating
procedures; and
``(iii) preparing reagents or other test
materials that do not meet the definition of a
in vitro clinical test for clinical use under
section 201(ss).
``(14) Low-risk.--The term `low-risk', with respect to an
in vitro clinical test or category of in vitro clinical tests,
means that an undetected inaccurate result from such in vitro
clinical test, or such category of in vitro clinical tests,
when used as intended by the developer--
``(A) would cause minimal or no harm, or minimal or
no disability, or immediately reversible harm, or would
lead to only a remote risk of adverse patient impact or
adverse public health impact, taking into account the
degree to which the technology for the intended use of
an in vitro clinical test or category of tests is well-
characterized and the criteria for performance of the
test or category of tests are well-established for the
intended use, the clinical circumstances under which
the in vitro clinical test or category of tests is
used, and the availability of other tests (such as
confirmatory or adjunctive tests); or
``(B) would cause a serious adverse health
consequence, harm that is reversible, a delay in
necessary treatment that is not life-supporting or
life-sustaining, or would lead to a serious risk of
adverse patient experience or adverse public health
impact, but applied mitigating measures have the
capacity to ensure the test meets the standard
described in subparagraph (A).
``(15) Mitigating measures.--The term `mitigating
measures'--
``(A) means controls, standards, or requirements
that the Secretary determines, based on available
evidence--
``(i) are necessary for an in vitro
clinical test, or a category of in vitro
clinical tests, to meet the applicable
standard; or
``(ii) to mitigate the risk of harm ensuing
from an inaccurate result such that a test or
category of tests subject to such mitigating
measures does not meet the definition of high
risk, or such that a test or category of tests
subject to such mitigating measures is low
risk; and
``(B) includes, as appropriate, applicable
requirements regarding labeling, conformance to
performance standards or guidance, performance testing,
submission of clinical data, advertising, website
posting of information, clinical studies, postmarket
surveillance, user comprehension studies, training, and
availability of confirmatory laboratory or clinical
findings.
``(16) Specimen receptacle.--The term `specimen receptacle'
means an in vitro clinical test specifically intended for the
holding, storing, or transporting of specimens derived from the
human body or for in vitro examination for purposes described
in clause (i) or (ii) of section 201(ss)(1)(A).
``(17) Technology.--The term `technology'--
``(A) means a developer's grouping of in vitro
clinical tests that do not significantly differ in
control mechanisms, energy sources, or operating
principals and for which design, development, and
manufacturing, including analytical and clinical
validation as applicable, of the tests would be
addressed in a similar manner or through similar
procedures; and
``(B) may include clot detection, colorimetric
(non-immunoassay), electrochemical (non-immunoassay),
enzymatic (non-immunoassay), flow cytometry,
fluorometry (non-immunoassay), immunoassay, mass
spectrometry or chromatography (such as HPLC),
microbial culture, next generation sequencing (also
known as `NGS'), nephlometric or turbidimetric (non-
immunoassay), singleplex or multiplex non-NGS nucleic
acid analysis, single-based technology, spectroscopy,
and any other technology, as the Secretary determines
appropriate.
``(18) Test.--The term `test', unless otherwise provided,
means an in vitro clinical test.
``(19) Valid scientific evidence.--The term `valid
scientific evidence'--
``(A) means, with respect to an in vitro clinical
test, evidence--
``(i) that has been generated and evaluated
by persons qualified by training or experience
to do so, using procedures generally accepted
by other persons so qualified; and
``(ii) from which it can be fairly and
responsibly concluded by qualified experts
whether the applicable standard has been met by
the in vitro clinical test for its intended
use; and
``(B) may include evidence described in
subparagraph (A) consisting of--
``(i) peer-reviewed literature;
``(ii) clinical guidelines;
``(iii) reports of significant human
experience with an in vitro clinical test;
``(iv) bench studies;
``(v) case studies or histories;
``(vi) clinical data;
``(vii) consensus standards;
``(viii) reference standards;
``(ix) data registries;
``(x) postmarket data;
``(xi) real world data;
``(xii) clinical trials; and
``(xiii) data collected in countries other
than the United States if such data are
demonstrated to be adequate for the purpose of
making a regulatory determination under the
applicable standard in the United States.
``(20) Well-characterized.--The term `well-characterized',
with respect to an in vitro clinical test, means well-
established and well-recognized by the scientific or clinical
community, if adequately evidenced by one or more of the
following:
``(A) Peer-reviewed literature.
``(B) Practice guidelines.
``(C) Consensus standards.
``(D) Recognized standards of care.
``(E) Technology in use for many years.
``(F) Scientific publication by multiple sites.
``(G) Adoption by the scientific or clinical
community.
``(H) Real world data.
``SEC. 587A. APPLICABILITY.
``(a) In General.--
``(1) Applicability of this subchapter.--
``(A) In general.--An in vitro clinical test shall
be subject to the requirements of this subchapter,
except as otherwise provided this subchapter.
``(B) Interstate commerce.--Any in vitro clinical
test that is offered for clinical use in the United
States is deemed to be introduced into interstate
commerce for purposes of enforcing the requirements of
this Act.
``(C) Non-applicable requirement.--Subject to any
exemption or exclusion in this section, an in vitro
clinical test shall not be subject to any provision or
requirement of this Act other than this subchapter
unless such other provision or requirement--
``(i) applies expressly to in vitro
clinical tests; or
``(ii) describes the authority of the
Secretary when regulating such in vitro
clinical tests or subset of in vitro clinical
tests, with respect to--
``(I) all articles regulated by the
Secretary pursuant to this Act; or
``(II) a subset of such articles
that includes in vitro clinical tests.
``(2) Laboratories and blood and tissue establishments.--
``(A) Relation to laboratory certification pursuant
to section 353 of the phsa.--Nothing in this subchapter
shall be construed to modify the authority of the
Secretary with respect to laboratories or clinical
laboratories under section 353 of the Public Health
Service Act.
``(B) Avoiding duplication.--In implementing this
subchapter, the Secretary shall avoid issuing or
enforcing regulations that are duplicative of
regulations under section 353.
``(C) Blood and tissue.--Nothing in this subchapter
shall be construed to modify the authority of the
Secretary with respect to laboratories, establishments,
or other facilities to the extent they are engaged in
the propagation, manufacture, or preparation, including
filling, testing, labeling, packaging, and storage, of
blood, blood components, human cells, tissues, or
tissue products under this Act or section 351 or 361 of
the Public Health Service Act.
``(3) Practice of medicine.--
``(A) In general.--Nothing in this subchapter shall
be construed to limit or interfere with the authority
of a health care practitioner to prescribe or
administer any legally marketed in vitro clinical test
for any condition or disease within a health care
practitioner-patient relationship pursuant to
applicable Federal or State law.
``(B) Rules of construction.--
``(i) Sale, distribution, labeling.--
Nothing in this paragraph shall be construed to
limit the authority of the Secretary to
establish or enforce restrictions on the sale,
distribution, or labeling of an in vitro
clinical test under this Act.
``(ii) Promotion of unapproved uses.--
Nothing in this paragraph shall be construed to
alter any prohibition on the promotion of
unapproved uses of legally marketed in vitro
clinical tests.
``(4) Special rule.--
``(A) Premarket review applicable.--Notwithstanding
the exemptions from premarket review under section 587B
set forth in subsections (b), (c), (d), (e), (f), (g),
(h), (j), and (k) of such section, an in vitro clinical
test (including any article for taking or deriving
specimens) shall be subject to the requirements of
section 587B if the Secretary determines, in accordance
with subparagraph (B), that--
``(i)(I) there is insufficient valid
scientific evidence to support the analytical
validity or the clinical validity of such in
vitro clinical test; and
``(II) such in vitro clinical test is being
offered by its developer with materially
deceptive or fraudulent analytical or clinical
claims;
``(ii) it is reasonably possible that such
in vitro clinical test will cause serious
adverse health consequences; or
``(iii) in the case of specimen
receptacles, there is sufficient valid
scientific evidence indicating that a specimen
receptacle did not perform as intended, will
not support the analytical validity of tests
with which it is used, or as applicable, is not
safe for use.
``(B) Process.--
``(i) Request for information.--If the
Secretary has valid scientific evidence
indicating that the criteria listed in
subparagraph (A) apply to an in vitro clinical
test, the Secretary may request that the
developer of the test submit information--
``(I) pertaining to such criteria;
and
``(II) establishing the basis for
any claimed exemption from premarket
review.
``(ii) Deadline for submitting
information.--The developer of an in vitro
clinical test shall submit the information
requested pursuant to clause (i) within 30 days
of receipt of such request.
``(iii) Review deadline.--Upon receiving a
submission under clause (ii), the Secretary
shall--
``(I) review the submitted
information within 60 calendar days of
such receipt; and
``(II) determine whether the
criteria listed in subparagraph (A)
apply to the in vitro clinical test.
``(iv) Premarket review required.--
``(I) In general.--If the Secretary
finds that the criteria listed in
subparagraph (A) apply to the in vitro
clinical test, the developer shall--
``(aa) promptly, and not
later than 90 days after the
date of receipt of such
information, submit an
application for premarket
review of the test under
section 587B; or
``(bb) cease to market the
test.
``(II) Extension.--The Secretary
may grant an extension to a developer
of the 90-day time period under
subclause (I)(aa), as appropriate.
``(v) Continued marketing.--During the
period beginning on the date of a request for
information under clause (ii) and ending on the
date of the disposition of an application for
premarket review of the in vitro clinical test
under section 587B, the developer of the test
may continue to market the test for clinical
use, unless the Secretary issues an order to
the developer under clause (vi) to immediately
cease distribution of the test.
``(vi) Order to cease distribution.--
``(I) In general.--If the developer
of an in vitro clinical test fails to
submit an application for premarket
review of the test by the deadline
applicable under clause (iv), or the
Secretary finds that the criteria
listed in subparagraph (A) apply to an
in vitro clinical test and that it is
in the best interest of the public
health, the Secretary may issue an
order, within 10 calendar days of the
applicable deadline or finding by the
Secretary, requiring the developer of
such in vitro clinical test, and any
other appropriate person (including a
distributor or retailer of the in vitro
clinical test) to immediately--
``(aa) cease distribution
of the test pending approval of
an application for premarket
review of the test under
section 587B; and
``(bb) notify health
professionals and other user
facilities of the order to
cease distribution and advise
health care professionals to
cease use of such in vitro
clinical test.
``(II) Hearing and review.--An
order under subclause (I) shall provide
the person subject to the order with an
opportunity for an informal hearing, to
be held not later than 10 days after
the date of the issuance of the order,
on the actions required by the order
and on whether the order should be
amended to require a recall of such in
vitro clinical test. If, after
providing an opportunity for such a
hearing, the Secretary determines that
inadequate grounds exist to support the
actions required by the order, the
Secretary shall terminate the order
within 30 days of the hearing. Upon
terminating an order, the Secretary
shall provide written notice of such
termination to the developer.
``(vii) Amendment to require recall.--If
the Secretary determines that an order issued
under clause (vi) should be amended to include
a recall of the in vitro clinical test with
respect to which the order was issued, the
Secretary shall amend the order to require a
recall. In such amended order, the Secretary
shall specify a timeframe in which the in vitro
clinical test recall will occur and shall
require periodic reports to the Secretary
describing the progress of the recall. Upon
termination of the recall, the Secretary shall
provide written notice of such termination to
the developer.
``(viii) Effect of test approval.--Any
order issued under this paragraph with respect
to an in vitro clinical test shall cease to be
in effect if such test is granted approval
under section 587B, provided that the in vitro
clinical test is developed and offered for
clinical use in accordance with such approval.
``(5) Emergency use.--
``(A) In general.--In the case of a determination
under section 319(a) of the Public Health Service Act
or a declaration under section 564(b) of this Act, an
in vitro clinical test is exempt from the requirements
of this subchapter and may be lawfully marketed in
accordance with subparagraph (B).
``(B) Criteria.--An in vitro clinical test is
exempt from the requirements of this subchapter and may
be lawfully marketed in accordance with the exemption
described in subparagraph (A) if--
``(i) such test--
``(I) is submitted for emergency
use authorization under section 564(b);
or
``(II) is developed and used in
laboratories for which a certificate is
in effect under section 353 of the
Public Health Service Act to conduct
high-complexity testing and the
developer; and
``(ii) the developer--
``(I) validates such in vitro
clinical test prior to use;
``(II) notifies the Secretary of
the assay validation; and
``(III) submits an emergency use
authorization application under section
564 within 15 calendar days of
marketing the test.
``(C) Disposition of product.--With respect to a
previously unapproved in vitro clinical test or an in
vitro clinical test with an unapproved use, for which
an emergency use authorization under section 564(b)
ceases to be effective, the Secretary shall consult
with the manufacturer of such product with respect to
the appropriate disposition of the product.
``(D) Streamlining of application review.--A
developer may include any data or information already
submitted to the Secretary within the emergency use
authorization as a part of a premarket application
under section 587B or a technology certification
application under section 587D.
``(6) Effect on other laws.--Any in vitro clinical test
that is lawfully marketed under this Act, including tests that
are approved under section 587B, cleared pursuant to an active
technology certification order under section 587D, or exempt
from premarket review under an exemption in this section, shall
be eligible for introduction into interstate commerce except as
otherwise provided in this subchapter.
``(b) Components and Parts.--
``(1) Exemption.--
``(A) In general.--Subject to subparagraph (B), a
component, part, or raw material described in section
201(ss)(1)(B)(v) is exempt from the requirements of
this subchapter if it is--
``(i) intended for further development as
described in paragraph (2); or
``(ii) otherwise to be regulated based on
its risk when used as intended by the
developer, notwithstanding its subsequent use
by a developer as a component, part, or raw
material of another in vitro clinical test.
``(B) Inapplicability to other tests.--
Notwithstanding subparagraph (A), an in vitro clinical
test that is described in section 201(ss)(1)(B) and
that uses a component or part described in such
subparagraph shall be subject to the requirements of
this subchapter, unless the test is otherwise exempt
under this section.
``(2) Further development.--A component, part, or raw
material (as described in paragraph (1)(A)) is intended for
further development (for purposes of such paragraph) if--
``(A) it is intended solely for use in the
development of another in vitro clinical test; and
``(B) in the case of such a test that is introduced
or delivered for introduction into interstate commerce
after the date of enactment of the Verifying Accurate
Leading-edge IVCT Development Act of 2021, the labeling
of such test bears the following statement: `This
product is intended solely for further development of
an in vitro clinical test and is exempt from FDA
regulation. This product must be evaluated by the in
vitro clinical test developer if it is used with or in
the development of an in vitro clinical test.'.
``(c) Grandfathered Tests.--
``(1) Exemption.--An in vitro clinical test that meets the
criteria set forth in paragraph (2) is exempt from the
requirements of this subchapter, except as provided under
subsection (a)(4), the registration and listing requirements
under section 587I, and the adverse reporting requirements
under section 587L, and may be lawfully marketed subject to the
other applicable requirements of this Act, if--
``(A) each test report template for the test bears
a statement of adequate prominence that reads as
follows: `This in vitro clinical test was developed and
first introduced prior to the date of enactment of the
Verifying Accurate Leading-edge IVCT Development Act of
2021 and has not been reviewed by the Food and Drug
Administration.'; and
``(B) the developer of the test--
``(i) maintains documentation demonstrating
that the test meets and continues to meet the
criteria set forth in paragraph (2); and
``(ii) makes such documentation available
to the Secretary upon request.
``(2) Criteria for exemption.--An in vitro clinical test is
exempt as specified in paragraph (1) if the test--
``(A)(i) was first offered for clinical use by such
laboratory before the date of enactment of the
Verifying Accurate Leading-edge IVCT Development Act of
2021;
``(ii) was developed by a clinical laboratory for
which a certificate was in effect under section 353 of
the Public Health Service Act that meets the
requirements under such section 353 for performing
high-complexity testing; and
``(iii) is performed--
``(I) in the same clinical laboratory in
which it was developed;
``(II) by another clinical laboratory for
which a certificate is in effect under section
353 within the same corporate organization and
having common ownership by the same parent
corporation; or
``(III) by a laboratory within a public
health laboratory network coordinated or
managed by the Centers for Disease Control and
Prevention;
``(B) does not have in effect an approval under
section 515, a clearance under section 510(k), an
authorization under section 513(f)(2), or an exemption
under section 520(m); and
``(C) is not modified on or after the date of
enactment of the Verifying Accurate Leading-edge IVCT
Development Act of 2021 by its initial developer (or
another person) in a manner such that the test is a new
in vitro clinical test under subsection (l).
``(3) Modifications.--In the case of a modification to an
in vitro clinical test that is exempt as specified in paragraph
(1) or such modification is otherwise not subject to premarket
review pursuant to section 587A(l), the test continues to
qualify for such exemption if the person modifying such test--
``(A) documents each such modification and
maintains a summary of the basis for such
determination; and
``(B) provides such documentation and summary to
the Secretary upon request or inspection.
``(d) Tests Exempt From Section 510(k).--
``(1) Exemption.--An in vitro clinical test is exempt from
premarket review under section 587B and may be lawfully
marketed subject to the other applicable requirements of this
Act, if the in vitro clinical test--
``(A)(i) was offered for clinical use prior to the
date of enactment of the Verifying Accurate Leading-
edge IVCT Development Act of 2021; and
``(ii) immediately prior to such date of enactment
was exempt pursuant to subsection (l) or (m)(2) of
section 510 from the requirements for submission of a
report under section 510(k); or
``(B)(i) was not offered for clinical use prior to
such date of enactment;
``(ii) is not a test platform; and
``(iii) falls within a category of tests that was
exempt from the requirements for submission of a report
under section 510(k) as of such date of enactment
(including class II devices and excluding class I
devices described in section 510(l)).
``(2) Effect on special controls.--For any in vitro
clinical test, or category of in vitro clinical tests, that is
exempt from premarket review based on the criteria in paragraph
(2), any special control that applied to a device within a
predecessor category immediately prior to the date of enactment
of Verifying Accurate Leading-edge IVCT Development Act of 2021
shall be deemed a mitigating measure applicable under section
587E to an in vitro clinical test within the successor
category, except to the extent such mitigating measure is
withdrawn or changed in accordance with section 587E.
``(3) Near-patient testing.--Not later than 1 year after
the date of enactment of the Verifying Accurate Leading-edge
IVCT Development Act of 2021, the Secretary shall issue draft
guidance indicating categories of tests that shall be exempt
from premarket review under section 587B when offered for near-
patient testing (point of care), which were not exempt from
submission of a report under section 510(k) pursuant to
subsection (l) or (m)(2) of section 510 and regulations
imposing limitations on exemption for in vitro devices intended
for near-patient testing (point of care).
``(e) Low-Risk Tests.--
``(1) Exemption.--An in vitro clinical test is exempt from
premarket review under section 587B and may be lawfully
marketed subject to the other applicable requirements of this
Act, including section 587I(b)(6), if such test meets the
definition of low-risk under section 587.
``(2) List of low-risk tests.--
``(A) In general.--The Secretary shall maintain,
and make publicly available on the website of the Food
and Drug Administration, a list of in vitro clinical
tests, and categories of in vitro clinical tests, that
are low-risk in vitro clinical tests for purposes of
the exemption under this subsection.
``(B) Inclusion.--The list under subparagraph (A)
shall consist of--
``(i) all in vitro clinical tests and
categories of in vitro clinical tests that are
exempt from premarket review pursuant to
subsection (d)(1) or (d)(3); and
``(ii) all in vitro clinical tests and
categories of in vitro clinical tests that are
designated by the Secretary pursuant to
subparagraph (C) as low-risk for purposes of
this subsection.
``(C) Designation of tests and categories.--Without
regard to subchapter II of chapter 5 of title 5, United
States Code, the Secretary may designate, in addition
to the tests and categories described in subparagraph
(B)(i), additional in vitro clinical tests, and
categories of in vitro clinical tests, as low-risk in
vitro clinical tests for purposes of the exemption
under this subsection. The Secretary may make such a
designation on the Secretary's own initiative or in
response to a request by any person. In making such a
designation for a test or category of tests, the
Secretary shall consider--
``(i) whether the test, or category of
tests, is low-risk; and
``(ii) such other factors as the Secretary
determines to be relevant to the protection of
the public health.
``(f) Manual Tests.--
``(1) Exemption.--An in vitro clinical test is exempt from
all requirements of this subchapter if the output of such in
vitro clinical test is the result of direct, manual
observation, without the use of automated instrumentation or
software for intermediate or final interpretation, by a
qualified laboratory professional, and such in vitro clinical
test--
``(A) is designed, manufactured, and used within a
single clinical laboratory for which a certificate is
in effect under section 353 of the Public Health
Service Act that meets the requirements under section
353 for performing high-complexity testing;
``(B) is not a high-risk test, or is a high-risk
test that the Secretary has determined meets at least
one condition in paragraph (2) and is otherwise
appropriate for this exemption; and
``(C) is not intended for testing donors,
donations, and recipients of blood, blood components,
human cells, tissues, cellular-based products, or
tissue-based products.
``(2) High-risk test limitation or condition.--A high-risk
test may be exempt under paragraph (1) from the requirements of
this subchapter only if--
``(A) no component or part of such test, including
any reagent, is introduced into interstate commerce
under the exemption under subsection (b)(1) (relating
to components or parts intended for further
development), and any article for taking or deriving
specimens from the human body used in conjunction with
the test remains subject to the requirements of this
subchapter; or
``(B) the test has been developed in accordance
with the applicable test design and quality
requirements under section 587J.
``(g) Humanitarian Test Exemption.--
``(1) In general.--An in vitro clinical test is exempt from
premarket review under section 587B and may be lawfully
marketed subject to the other applicable requirements of this
Act, if--
``(A) such in vitro clinical test is intended for
use for a disease or condition for which no more than
10,000 (or such other number determined by the
Secretary) individuals would be subject to negative or
positive diagnosis by such test in the United States
per year; and
``(B) the developer of the test--
``(i) maintains documentation (which may
include literature citations in specialized
medical journals, textbooks, specialized
medical society proceedings, governmental
statistics publications, or, if no such studies
or literature citations exist, credible
conclusions from appropriate research or
surveys) demonstrating that such test meets and
continues to meet the criteria described in
this paragraph; and
``(ii) makes such documentation available
to the Secretary upon request.
``(2) Cross-referenced tests.--In order to be eligible for
an exemption under this subsection, the developer of a cross-
referenced test shall submit a request under section 587H for
informal feedback.
``(h) Custom Tests and Low-Volume Tests.--An in vitro clinical test
is exempt from premarket review under section 587B, the quality
requirements under section 587J, and the notification requirements
under section 587I, and may be lawfully marketed subject to the other
applicable requirements of this Act, if--
``(1) such in vitro clinical test--
``(A) is a low-volume test performed in a
laboratory in which it was developed or developed in a
laboratory within the same corporate organization with
the laboratory in which such test is performed and is
administered to no more than 5 patients per year,
unless otherwise determined by the Secretary; or
``(B) is a custom test developed or modified to
diagnose a unique pathology or physical condition of a
specific patient for which no other in vitro clinical
test is commercially available in the United States,
and is--
``(i) not intended for use with respect to
other patients; and
``(ii) after the development of the custom
test, not included in any test menu, template
test report, or other promotional materials,
and not otherwise advertised; and
``(2) the developer of the test--
``(A) maintains documentation demonstrating that
such test meets and continues to meet the applicable
criteria described in paragraph (1);
``(B) makes such documentation, such as a
prescription order requesting the custom test for an
individual patient, available to the Secretary upon
request; and
``(C) informs the Secretary, on an annual basis, in
a manner prescribed by the Secretary by guidance, that
such test was introduced into interstate commerce.
``(i) Public Health Surveillance Activities.--
``(1) In general.--The provisions of this subchapter shall
not apply to a test intended by the developer to be used solely
for public health surveillance activities, including the
collection and testing of information or biospecimens,
conducted, supported, requested, ordered, required, or
authorized by a public health authority.
``(2) Limitation.--The public health surveillance
activities described in paragraph (1)--
``(A) are limited to activities necessary to allow
a public health authority to identify, monitor, assess,
or investigate potential public health signals, onsets
of disease outbreaks, or conditions of public health
importance (including trends, risk factors, patterns in
diseases, and increases in injuries from using consumer
products); and
``(B) include activities associated with providing
timely situational awareness and priority setting
during the course of a threat to the public health
(including natural or man-made disasters and deliberate
attacks on the United States).
``(3) Exclusion.--An in vitro clinical test is not excluded
from the provisions of this subchapter if such test is intended
for use in making clinical decisions for individual patients.
``(j) Law Enforcement or Employer Testing.--An in vitro clinical
test that is intended solely for use in forensic analysis, law
enforcement activity, or employment purposes is exempt from the
requirements of this Act. An in vitro clinical test that is intended
for use in making clinical decisions for individual patients, or whose
individually identifiable results may be reported back to an individual
patient or the patient's health care provider, even if also intended
for law enforcement or employment testing purposes, is not intended
solely for use in law enforcement or employment testing for purposes of
this subsection.
``(k) In Vitro Clinical Tests Under a Technology Certification
Order.--An in vitro clinical test that is within the scope of a
technology certification order, as described in section 587D(a), is
exempt from premarket review under section 587B.
``(l) Modified Tests.--
``(1) In general.--An in vitro clinical test that is
modified, by the initial developer of the test or a different
person, is a new in vitro clinical test subject to the
requirements of this subchapter if the modification--
``(A) affects the analytical or clinical validity
of such test;
``(B) causes the test to no longer comply with
applicable mitigating measures under section 587E or
restrictions under section 587N; or
``(C) as applicable, affects the safety of an
article for taking or deriving specimens from the human
body for a purpose described in section 201(ss)(1).
``(2) Exemptions.--Notwithstanding paragraph (1), an in
vitro clinical test that is modified by the initial developer
of the test or a different person is not a new in vitro
clinical test if the modification--
``(A) is a software update that does not have an
adverse effect on the analytical or clinical validity
or result in an increased risk to patients and
consumers;
``(B) is made pursuant to methods or criteria
included in the change protocol premarket submission,
amendment, or supplement approved by the Secretary for
the in vitro clinical test being modified;
``(C) is a labeling change that is appropriate to
address patient or user harm; or
``(D) is a specimen-related modification that--
``(i) is made to extend specimen stability;
or
``(ii) aligns with the data and information
submitted in an approved application for
premarket review under section 587B or a
technology certification order issued under
section 587D.
``(3) Documentation.--When a person modifies an in vitro
clinical test that was developed by another person, such
modified test is exempt from the requirements of this
subchapter provided that such person--
``(A) documents the modification that was made and
the basis for determining that the modification,
considering the changes individually and collectively,
was not a type of modification described in paragraph
(1); and
``(B) provides such documentation to the Secretary
upon request or inspection.
``(m) Investigational Use.--An in vitro clinical test for
investigational use is exempt from the requirements of this Act, except
as provided in section 587R.
``(n) Transfer or Sale of In Vitro Clinical Tests.--
``(1) Transfer and assumption of regulatory obligations.--
If ownership of an in vitro clinical test is sold or
transferred in such manner that the developer transfers the
regulatory submissions and obligations applicable under this
subchapter with respect to the test, the transferee or
purchaser becomes the developer of the test and shall have all
regulatory obligations applicable to such a test under this
subchapter. The transferee or purchaser shall update the
registration and listing information under section 587I for the
in vitro clinical test.
``(2) Transfer or sale of premarket approval.--
``(A) Notice required.--If a developer of an in
vitro clinical test transfers or sells the approval of
the in vitro clinical test, the transferor or seller
shall--
``(i) submit a notice of the transfer or
sale to the Secretary and update the
registration and listing information under
section 587I for the in vitro clinical test;
and
``(ii) submit a supplemental application if
required under section 587B(h).
``(B) Effective date of approval transfer.--A
transfer or sale described in subparagraph (A) shall
become effective upon completion of a transfer or sale
described in paragraph (1) or the approval of a
supplemental application under section 587B(h) if
required, whichever is later. The transferee or
purchaser shall update the registration and listing
information under section 587I for the in vitro
clinical test within 15 calendar days of the effective
date of the transfer or sale.
``(3) Transfer or sale of technology certification.--
``(A) Requirements for transfer or sale of
technology certification.--An unexpired technology
certification can be transferred or sold if the
transferee or purchaser--
``(i) is an eligible person under section
587D(b)(1); and
``(ii) maintains, upon such transfer or
sale, the site, test design and quality
requirements, processes and procedures under
the scope of technology certification, and
scope of the technology certification
identified in the applicable technology
certification order.
``(B) Notice required.--If a developer of an in
vitro clinical test transfers or sells a technology
certification order that has not expired, the
transferor or seller shall submit a notice of the
transfer or sale to the Secretary and shall update the
registration and listing information under section 587I
for all in vitro clinical tests covered by the
technology certification.
``(C) Effective date of technology certification
transfer.--The transfer of a technology certification
shall become effective upon completion of a transfer or
sale described in subparagraph (A). The transferee or
purchaser shall update the registration and listing
information under section 587I for the in vitro
clinical test within 30 calendar days of the effective
date of the technology certification transfer.
``(D) New technology certification required.--If
the requirements of subparagraph (A)(ii) are not met,
the technology certification order may not be
transferred and the transferee or purchaser of an in
vitro clinical test is required to submit an
application for technology certification and obtain a
technology certification order prior to offering the
test for clinical use.
``(o) General Laboratory Equipment.--Any instrument that does not
produce an analytical result, and that functions as a component of pre-
analytical procedures related to in vitro clinical tests, is not
subject to the requirements of this subchapter, provided that--
``(1) the instrument is operating in a clinical laboratory
that is certified under section 353 of the Public Health
Service Act; and
``(2) the instrument can be serviced by the manufacturer of
such instrument or, if that manufacturer is no longer in
business, a third party with the ability to service such
instrument.
``(p) Instrument Families.--In the case of an instrument family,
premarket approval under section 587B(d) of one version of the in vitro
clinical test is required, and previous and updated versions of the
same test within such instrument family shall be deemed to be subject
to the approval pursuant to that section, unless the Secretary
determines otherwise, as set forth in guidance.
``(q) General Exemption Authority.--The Secretary may, by order
published in the Federal Register following notice and an opportunity
for comment, exempt a class of persons from any section under this
subchapter upon a finding that such exemption is appropriate for the
protection of the public health and other relevant considerations.
``(r) Regulations.--The Secretary may issue regulations to
implement this subchapter.
``SEC. 587B. PREMARKET REVIEW.
``(a) In General.--No person shall introduce or deliver for
introduction into interstate commerce any in vitro clinical test,
unless--
``(1) an approval of an application filed pursuant to
subsection (c) or (d) is effective with respect to test; or
``(2) the test is exempt under section 587A from premarket
review under this section.
``(b) Transparency and Predictability.--
``(1) Pre-submission meeting or request for informal
feedback.--Pursuant to section 587H, prior to filing an
application under subsection (c) or (d), any person may request
a meeting or written correspondence with the Secretary to
discuss the eligibility of an in vitro clinical test for
premarket review or other information related to the filing of
an application. The Secretary shall respond to such request
within 45 calendar days.
``(2) Streamlining of applications.--
``(A) Premarket application and technology
certification.--If a person files a premarket
application under this section and provides any
additional documentation required under section 587D,
the in vitro clinical test that is the subject of the
application may be utilized as the representative test
reviewed by the Secretary to provide an approval for
both a premarket application under this section and a
technology certification order under section 587D.
``(B) Representative assays for premarket
approval.--With respect to a technology certification
application filed under section 587D, the
representative test, as described in subparagraph (A),
used to issue a technology certification order under
section 587D shall be deemed a test with premarket
approval under this section.
``(c) Application.--
``(1) Filing.--Any person may file with the Secretary an
application for premarket approval of an in vitro clinical
test.
``(2) Application content.--An application submitted under
paragraph (1) with respect to an in vitro clinical test shall
include the following, in such format as the Secretary
specifies:
``(A) General information regarding the in vitro
clinical test, including--
``(i) the name and address of the
applicant;
``(ii) the table of contents for the
application and the identification of the
information the applicant claims as trade
secret or confidential commercial or financial
information;
``(iii) a description of the test's
intended use;
``(iv) an explanation regarding test
function and any significant performance
characteristics; and
``(v) an explanation of how the development
and validation activities support the test
meeting the applicable standard.
``(B) A summary of the data and information in the
application for the in vitro clinical test, including--
``(i) a brief description of any existing
alternative practices or procedures for
diagnosing the disease or condition for which
the in vitro clinical test is intended, as
applicable;
``(ii) a brief description of the foreign
and domestic marketing history of the test, if
any, including a list of all countries in which
the test has been marketed and a list of all
countries in which the test has been withdrawn
from marketing for any reason related to the
applicable standard of the in vitro clinical
test, if known by the applicant;
``(iii) a summary of the any studies
submitted for such test, including a
description of the objective of the study, a
description of the experimental design of the
study, a brief description of how the data were
collected and analyzed, a brief description of
the results of the technical data submitted,
and a brief description of any nonclinical or
clinical studies;
``(iv) a risk assessment of the test; and
``(v) conclusions drawn from any studies
described in clause (iii), including a
discussion demonstrating that the data and
information in the application constitute valid
scientific evidence and meet the applicable
standard under section 587(2), an explanation
of how the development and validation
activities, as applicable, support that the
test meets the applicable standard under
section 587(2), and a discussion of any adverse
effects of the test on health and proposals to
mitigate those risks, if any.
``(C) The signature of the person filing the
premarket application or an authorized representative.
``(D) A bibliography of all published reports
reasonably known to the applicant related to such test
and a discussion of data and information relevant to
the evaluation of the applicable standard that may be
met by such test.
``(E) A statement that the applicant believes to
the best of the applicant's knowledge that all data and
information submitted to the Secretary are truthful and
accurate and that no material fact has been omitted in
the application.
``(F) Except as provided under subsection (d),
applicable information regarding the methods used in,
or the facilities or controls used for, the development
of the test to demonstrate compliance with the
applicable quality requirements under section 587J.
``(G) Information demonstrating compliance with any
relevant--
``(i) mitigating measures under section
587E; and
``(ii) standards established or recognized
under section 514 prior to the date of
enactment of the Verifying Accurate Leading-
edge IVCT Development Act of 2021, or, after
applicable standards are established or
recognized under section 587Q, with such
standards.
``(H) Valid scientific evidence to support
analytical and clinical validity of the test, which
shall include--
``(i) summary information for all
supporting validation studies performed;
``(ii) raw data, such as tabulations of
data and results as required under section
814.20(b)(6)(ii) of title 21, Code of Federal
Regulations (or any successor regulations);
``(iii) for nonclinical laboratory studies
involving the test, a statement that studies
were conducted in compliance with applicable
good laboratory practices; and
``(iv) for investigations involving human
subjects, statements that any clinical
investigation involving human subjects was
conducted in compliance with applicable--
``(I) institutional review board
regulations;
``(II) informed consent
regulations; and
``(III) investigational use
requirements in section 587R.
``(I) To the extent the application seeks
authorization to make modifications to the test within
the scope of the approval, a change protocol that
includes validation procedures and acceptance criteria
for anticipated modifications that could be made to the
test within the scope of the approval.
``(J) Proposed labeling, in accordance with the
requirements of section 587K.
``(K) Such other data or information as the
Secretary may require in accordance with the least
burdensome requirements of subsection (j).
``(3) Guidance for premarket and special premarket
applications.--In accordance with section 5 of the Verifying
Accurate Leading-edge IVCT Development Act of 2021, the
Secretary shall issue draft guidance detailing the information
to be provided in a premarket application and special premarket
application under this section. The Secretary shall issue final
guidance not later than 90 calendar days after the close of the
comment period for such guidance.
``(4) Refuse to file a premarket or special premarket
application.--If, after receipt of an application under this
section, the Secretary refuses to file such application, the
Secretary shall provide to the developer, within 60 calendar
days of receipt of such application, a description of the
reason for such refusal, and identify the information required,
if any, to allow for the filing of the application.
``(5) Substantive review for deficient application.--If,
after receipt of an application under this section, the
Secretary determines that any portion of such application is
deficient, the Secretary shall provide to the applicant, within
75 calendar days of receipt of such application, a description
of such deficiencies and identify the information required to
correct such deficiencies.
``(d) Special Premarket Review.--
``(1) In general.--Any person may file with the Secretary
an application for special premarket approval for--
``(A) an instrument;
``(B) a specimen receptacle;
``(C) an in vitro clinical test eligible for a
technology certification order under section 587D; or
``(D) a first-of-a-kind test (unless it is a high-
risk test), a direct-to-consumer test, or cross-
referenced test that does not have mitigating measures.
``(2) Application content.--An application under paragraph
(1) shall include--
``(A) the information required for applications
submitted under subsection (c)(2), except that
applications under paragraph (1) need not include--
``(i) quality requirement information; or
``(ii) raw data unless explicitly requested
by the Secretary;
``(B) in the case of a specimen receptacle, safety
information; and
``(C) data, as applicable, to support software
validation, electromagnetic compatibility, and
electrical safety, and information demonstrating
compliance with maintaining quality systems
documentation.
``(3) Inspections.--With respect to an application under
paragraph (1), preapproval inspections authorized by an
employee of the Food and Drug Administration or a person
accredited under section 587P need not occur unless requested
by the Secretary.
``(e) Instrument Family.--When an in vitro clinical test has been
approved, or is otherwise legally marketed, for use on a specific
approved or legally marketed instrument within an instrument family, a
submission under this section shall not be required for that in vitro
clinical test in order for it to be used on a new instrument within
that instrument's family.
``(f) Amendments to an Application.--
``(1) In general.--An applicant may amend an original or
supplemental application under subsection (c) or (d).
``(2) Required amendment or supplement.--An applicant shall
amend or supplement an application submitted under subsection
(c) or (d) if the applicant becomes aware of information that--
``(A) could reasonably affect an evaluation of
whether the applicable standard has been met; or
``(B) could reasonably affect the statement of
contraindications, warnings, precautions, and adverse
reactions in the proposed labeling.
``(3) Request for amendment or supplement.--The Secretary
may request that an applicant amend or supplement an
application under subsection (c) or (d) with any information
necessary for review under this section.
``(g) Action on an Application for Premarket Approval.--
``(1) Review.--
``(A) Disposition.--As promptly as possible, but
not later than 90 calendar days after an application
under subsection (c) is accepted for submission (unless
the Secretary determines that an extension is necessary
to review one or more major amendments to the
application), or not later than 60 calendar days after
an application under subsection (d) is accepted for
submission, the Secretary, after considering any
applicable report and recommendations pursuant to
advisory committees under section 587G, or prior to the
establishment of such advisory committees, any
recommendations by a classification panel under section
513, shall issue an order approving the application,
unless the Secretary finds that the grounds for
approval in paragraph (2) are not met.
``(B) Reliance on proposed labeling.--In
determining whether to approve or deny an application
under paragraph (1), the Secretary shall rely on the
intended use included in the proposed labeling,
provided that such labeling is not false or misleading
based on a fair evaluation of all material facts.
``(2) Approval of an application.--
``(A) In general.--The Secretary shall approve an
application submitted under subsection (c) with respect
to an in vitro clinical test if the Secretary finds
that there is a reasonable assurance that the
applicable standard is met, and--
``(i) except as provided under subsection
(d), the applicant is in compliance with
applicable quality requirements in section 587J
or as otherwise specified in a condition of
approval, or maintains the documentation
required to be in compliance with such
requirements if the applicant is not required
to submit such documentation as a part of the
application under this section;
``(ii) the application does not contain a
false statement of material fact;
``(iii) based on a fair evaluation of all
material facts, the proposed labeling is
truthful and non-misleading and complies with
the requirements of section 587K;
``(iv) except as provided under subsection
(d), the applicant permits, if requested,
authorized employees of the Food and Drug
Administration and persons accredited under
section 587P an opportunity--
``(I) to inspect at a reasonable
time and in a reasonable manner the
facilities and all pertinent equipment,
finished and unfinished materials,
containers, and labeling therein,
including all things (including
records, files, papers, and controls)
bearing on whether an in vitro clinical
test is adulterated, misbranded, or
otherwise in violation of this Act; and
``(II) to view and to copy and
verify all records pertinent to the
application and the in vitro clinical
test;
``(v) the test conforms with any applicable
performance standards under section 587Q and
any applicable mitigating measures under
section 587E; and
``(vi) all nonclinical laboratory studies
and clinical investigations involving human
subjects that are described in the application
were conducted in a manner that meets the
requirements of this section.
``(B) Conditions of approval.--An order approving
an application pursuant to this paragraph may require
conditions of approval for the in vitro clinical test,
including conformance with performance standards under
section 587Q and restrictions under section 587N.
``(C) First-of-a-kind test.--For a first-of-a-kind
in vitro clinical test, an order approving an
application pursuant to this paragraph--
``(i) may impose requirements for tests
with the same indications for use, including
conformance with performance standards under
section 587Q and mitigating measures under
section 587E, and comply with restrictions
under section 587N; and
``(ii) shall indicate whether subsequent in
vitro clinical tests with the same intended use
may meet an exemption set forth in section
587A.
``(D) Publication.--The Secretary shall publish
each order approving an application pursuant to this
paragraph on the public website of the Food and Drug
Administration and make publicly available a summary of
the data used to grant the approval, except to the
extent the Secretary determines that such order--
``(i) contains commercially confidential or
trade secret information; or
``(ii) relates to national security or
countermeasures is restricted from disclosure
pursuant to statutory provisions other than
this section.
``(3) Review of denials.--An applicant whose application
submitted under subsection (c) or (d) has been denied approval
may, by petition filed not more than 60 calendar days after the
date on which the applicant receives notice of such denial,
obtain review of the denial in accordance with section 587O.
``(h) Supplements to an Application.--
``(1) Risk analysis.--Prior to implementing any
modification to an in vitro clinical test, the holder of the
application approved under subsection (c) or (d) for such test
shall perform risk analyses in accordance with section 587J,
unless such modification is included in the change protocol
submitted by the applicant and approved under this section or
exempt under section 587A(l).
``(2) Supplement requirement.--
``(A) In general.--Except as provided in
subparagraph (B), or otherwise specified by the
Secretary, the holder of the application approved under
subsection (g) for an in vitro clinical test shall
submit to the Secretary and receive approval of a
supplement before implementing a modification to the
test, unless such modification is exempt under section
587A(l).
``(B) Adjustments to change protocol.--A person may
submit under this paragraph a supplemental application
adjusting the change protocol of the test at any time
after the initial filing of an application under
subsection (c) or (d).
``(C) Exceptions.--Subject to subparagraphs (D) and
(E), and so long as the holder of an approved
application submitted under subsection (c) or (d) for
an in vitro clinical test does not add a manufacturing
site, or change activities at an existing manufacturing
site, with respect to the test, the holder may, without
prior approval of a supplement, implement the following
modifications to the test:
``(i) Modifications included in and
implemented in accordance with an approved
change protocol under subsection (c)(2)(I).
``(ii) Modifications that do not change--
``(I) the analytical or clinical
validity of the test;
``(II) the intended use of the test
unless provided under an approved
change protocol under subsection
(c)(2)(I); or
``(III) the safety of the specimen
receptacles.
``(iii) Labeling changes to appropriately
address a safety concern.
``(iv) Modifications that are exempt under
section 587A(l).
``(D) Reporting for change protocol
modifications.--As a component of the report required
under subsection (k), the holder of an application
approved under subsection (g) for an in vitro clinical
test shall--
``(i) report any modification to the test
described in clause (i) or (ii) of subparagraph
(C) in the next annual report for the test
under subsection (k) following the date on
which the test, with such modification, is
introduced into interstate commerce; and
``(ii) include in such report--
``(I) a description of the
modification; and
``(II) as applicable, a summary of
the analytical validity and clinical
validity of the test, as modified, and
any changes to acceptance criteria.
``(E) Reporting for other category of exceptions.--
The holder of the application approved under subsection
(c) or (d) for an in vitro clinical test shall--
``(i) report to the Secretary any
modification to the test described in clause
(iii) of subparagraph (C) not more than 60 days
after the date on which the test, with the
modification, is introduced into interstate
commerce; and
``(ii) include in the report--
``(I) a summary of the relevant
change or changes;
``(II) the rationale for
implementing such change or changes;
and
``(III) a description of how the
change or changes were evaluated.
``(F) Request for supplement.--Upon review of the
information received under subparagraph (D) and a
finding that the relevant modification is inconsistent
with the standard specified under subparagraph (C), the
Secretary may require a supplement under subparagraph
(A). If the Secretary determines that a supplement
under subparagraph (A) is required, the Secretary shall
notify the applicant of such determination. Such
notification shall include a justification for the
submission of a supplement. Prior to the submission of
a supplement under this subparagraph, the applicant may
request a meeting or written correspondence to gain
agency feedback as to the necessity of such
supplemental filing. The Secretary shall respond to
such meeting request within 30 calendar days of
receipt.
``(3) Contents of supplement.--Unless otherwise specified
by the Secretary, a supplement under this subsection shall
include--
``(A) for modifications other than manufacturing
site changes--
``(i) a description of the modification;
``(ii) data to demonstrate that the
applicable standard is met;
``(iii) acceptance criteria; and
``(iv) any revised labeling; and
``(B) for manufacturing site changes--
``(i) the information listed in
subparagraph (A); and
``(ii) information regarding the methods
used in, or the facilities or controls used
for, the development of the test to demonstrate
compliance with the applicable quality
requirements under section 587J.
``(4) Additional data.--The Secretary may require, when
necessary, data to evaluate a modification to an in vitro
clinical test that is in addition to the data otherwise
required under the preceding paragraphs if the data request is
in accordance with the least burdensome requirements under
subsection (j).
``(5) Conditions of approval.--In an order approving a
supplement under this subsection, the Secretary may require
conditions of approval for the in vitro clinical test,
including compliance with restrictions under section 587N and
conformance to performance standards under section 587Q.
``(6) Approval.--The Secretary shall approve a supplement
under this subsection if--
``(A) the data demonstrate that the modified in
vitro clinical test meets the applicable standard; and
``(B) the holder of the application approved under
subsection (g) for the test has demonstrated compliance
with applicable quality and inspection requirements, as
applicable and appropriate.
``(7) Publication.--The Secretary shall publish on the
public website of the Food and Drug Administration notice of
any order approving a supplement under this subsection, except
that such publication shall exclude--
``(A) commercial confidential or trade secret
information; and
``(B) any other information that the Secretary
determines to relate to national security or
countermeasures or to be restricted from disclosure
pursuant to another provision of law.
``(8) Review of denial.--An applicant whose supplement
under this subsection has been denied approval may, by petition
filed on or before the 60th calendar day after the date upon
which the applicant receives notice of such denial, obtain
review of the denial in accordance with section 587O.
``(i) Withdrawal and Temporary Suspension of Approval.--
``(1) Order withdrawing approval.--
``(A) In general.--The Secretary may, within 10
calendar days of providing due notice and an
opportunity for an informal hearing to the holder of an
approved application for an in vitro clinical test
under this section, issue an order withdrawing approval
of the application if the Secretary finds that--
``(i) the grounds for approval under
subsection (g) are no longer met; or
``(ii) there is a reasonable likelihood
that the test would cause death or serious
adverse health consequences, including by
causing the absence, delay, or discontinuation
of life-saving or life sustaining medical
treatment.
``(B) Content.--An order under subparagraph (A)
withdrawing approval of an application shall state each
ground for withdrawal and shall notify the holder of
such application 60 calendar days prior to issuing such
order.
``(C) Publication.--The Secretary shall publish any
order under subparagraph (A) on the public website of
the Food and Drug Administration, except that such
publication shall exclude--
``(i) commercial confidential or trade
secret information; and
``(ii) any other information that the
Secretary determines to relate to national
security or countermeasures or to be restricted
from disclosure pursuant to another provision
of law.
``(2) Order of temporary suspension.--If, after providing
due notice and an opportunity for an informal hearing to the
holder of an approved application for an in vitro clinical test
under this section, the Secretary determines there is a
reasonable likelihood that the in vitro clinical test would
cause death or serious adverse health consequences, including
by causing the absence, delay, or discontinuation of life-
saving or life-sustaining medical treatment, the Secretary
shall by order temporarily suspend the approval of the
application. If the Secretary issues such an order, the
Secretary shall proceed expeditiously under paragraph (1) to
withdraw approval of such application.
``(j) Least Burdensome Requirements.--
``(1) In general.--In carrying out this subchapter, the
Secretary shall consider the least burdensome means necessary
to provide a reasonable assurance of analytical and clinical
validity, or applicable standard, and other regulatory
requirements, as determined by the Secretary.
``(2) Necessary defined.--For purposes of paragraph (1) and
paragraph (3), the term `necessary' means the minimum required
information that would support a determination by the Secretary
that the application provides a reasonable assurance of
analytical and clinical validity, or other applicable standard
or regulatory requirement, as determined by the Secretary.
``(3) Consideration of role of postmarket information.--For
purposes of this subsection, the Secretary shall consider the
role of postmarket information in determining the least
burdensome appropriate means necessary to demonstrate that the
applicable standard and other regulatory requirements have been
met.
``(k) Annual Report.--
``(1) In general.--Unless the Secretary specifies
otherwise, the holder of an approved application under this
section shall submit an annual report each year at a time
designated by the Secretary in the approval order. Such report
shall--
``(A) identify all modifications required to be
reported that an approved application holder has made
to any test that is covered by the approval order,
including any modification that requires a supplement
under subsection (h)(2); and
``(B) include any other information required by the
Secretary.
``(2) Exception.--The annual reporting requirement in
paragraph (1) shall not apply to in vitro clinical tests that
are deemed to have a premarket approval based on a prior
approval under section 515(c), clearance under section 510(k),
or authorization under section 513(f) of this Act, or that are
grandfathered under 587A(c).
``(l) Service of Orders.--Orders of the Secretary under this
section with respect to applications under subsection (c) or (d) or
supplements under subsection (h) shall be served--
``(1) in person by any officer or employee of the
Department of Health and Human Services designated by the
Secretary; or
``(2) by mailing the order by registered mail or certified
mail or electronic equivalent addressed to the applicant at the
last known address in the records of the Secretary.
``SEC. 587C. BREAKTHROUGH IN VITRO CLINICAL TESTS.
``(a) In General.--The purpose of this section is to encourage the
Secretary to apply efficient and flexible approaches to expedite the
development of, and prioritize the review of, in vitro clinical tests
that represent breakthrough technologies, and to provide the Secretary
with sufficient authority to do so.
``(b) Establishment of Program.--The Secretary shall establish a
program to expedite the development of, and provide for the priority
review of, in vitro clinical tests.
``(c) Eligibility.--The program developed under subsection (b)
shall be available for any in vitro clinical test that--
``(1) provides or enables more effective treatment or
diagnosis of life-threatening or irreversibly debilitating
human disease or conditions compared to existing approved or
precertified alternatives; and
``(2) is a test--
``(A) that represents a breakthrough technology;
``(B) for which no approved or precertified
alternative exists;
``(C) that offers a clinically meaningful advantage
over existing approved or precertified alternatives,
including the potential, compared to existing approved
or precertified alternatives, to reduce or eliminate
the need for hospitalization, improve patient quality
of life, facilitate patients' ability to manage their
own care (such as through self-directed personal
assistance), or establish long-term clinical
efficiencies; or
``(D) the availability of which is in the best
interest of patients or public health.
``(d) Designation.--
``(1) Request.--To receive breakthrough approval under this
section, an applicant may request that the Secretary designate
the in vitro clinical test for expedited development and
priority review. Any such request for designation may be made
at any time prior to the submission of an application under
section 587B, and shall include information demonstrating that
the test is eligible for designation under subsection (c).
``(2) Determination.--Not later than 60 calendar days after
the receipt of a request under paragraph (1), the Secretary
shall determine whether the in vitro clinical test that is the
subject of the request meets the criteria described in
subsection (c). If the Secretary determines that the test meets
the criteria, the Secretary shall designate the test for
expedited development and priority review.
``(3) Review.--Review of a request under paragraph (1)
shall be undertaken by a team that is composed of experienced
staff and senior managers of the Food and Drug Administration.
``(4) Withdrawal.--
``(A) In general.--The designation of an in vitro
clinical test under this subsection is deemed to be
withdrawn, and such in vitro clinical test shall no
longer be eligible for designation under this section,
if an application for approval under section 587B is
denied. Such test shall be eligible for designation
upon a new request for such designation.
``(B) Exception.--The Secretary may not withdraw a
designation granted under this subsection based on the
subsequent approval or technology certification of
another test that--
``(i) is designated under this section; or
``(ii) was given priority review under
section 515B.
``(e) Actions.--For purposes of expediting the development and
review of in vitro clinical tests under this section, the Secretary may
take the actions and additional actions set forth in paragraphs (1) and
(2), respectively, of section 515B(e) when reviewing such tests. Any
reference or authorization in section 515B(e) with respect to a device
shall be deemed a reference or authorization with respect to an in
vitro clinical test for purposes of this section.
``(f) Guidance.--
``(1) In general.--Not later than one year after the date
of enactment of the Verifying Accurate Leading-edge IVCT
Development Act of 2021, the Secretary shall issue draft
guidance on the implementation of this section. Such guidance
shall--
``(A) set forth the process by which a person may
seek a designation under subsection (d);
``(B) provide a template for request under
subsection (d);
``(C) identify the criteria the Secretary will use
in evaluating a request for designation; and
``(D) identify the criteria and processes the
Secretary will use to assign a team of staff, including
team leaders, to review in vitro clinical tests
designated for expedited development and priority
review, including any training required for such
personnel to ensure effective and efficient review.
``(2) Process.--Prior to finalizing the guidance under
paragraph (1), the Secretary shall seek public comment on the
draft guidance. The Secretary shall issue final guidance one
year after the close of the comment period for the draft
guidance.
``(g) Annual Report.--Unless otherwise specified by the Secretary,
the requirements under section 587B(k) apply to in vitro clinical tests
designated under this section.
``(h) Service of Orders.--Orders of the Secretary under this
section shall be served--
``(1) in person by any officer or employee of the
Department of Health and Human Services designated by the
Secretary; or
``(2) by mailing the order by registered mail or certified
mail or electronic equivalent addressed to the applicant at his
last known address in the records of the Secretary.
``SEC. 587D. TECHNOLOGY CERTIFICATION.
``(a) In General.--
``(1) Eligibility.--Any eligible person may seek a
technology certification order in accordance with this section.
``(2) Exception.--An in vitro clinical test is exempt from
premarket review under section 587B and may be introduced into
interstate commerce if the developer is eligible under this
section and the in vitro clinical test--
``(A) is an eligible in vitro clinical test under
subsection (b)(2); and
``(B) falls within the scope of a technology
certification order issued under this section that is
in effect.
``(b) Eligibility.--
``(1) Eligible person.--In this section, the term `eligible
person' means an in vitro clinical test developer unless, at
the time such person seeks or would seek technology
certification order, the person--
``(A) has been found to have committed a
significant violation of section 353 of the Public
Health Service Act, unless--
``(i) such violation occurred more than 5
years prior to the date on which such
technology certification order is or would be
sought; or
``(ii) such violation has been resolved;
``(B) fails to maintain required certifications
under section 353 of the Public Health Service Act, as
applicable; or
``(C) has been found to have submitted information
to the Secretary that--
``(i) makes false or misleading statements
about a technology certification order
previously issued or an application approved
under section 587B; or
``(ii) violates any requirement of this
subchapter, where such violation exposes
individuals to serious risk of illness, injury,
or death.
``(2) Technology certification eligibility limitations.--An
in vitro clinical test is not eligible under subsection (a)(2)
for exemption from premarket review under section 587B, if--
``(A) such test is--
``(i) a component or part of an in vitro
clinical test as described in section
201(ss)(1)(B)(v);
``(ii) an instrument under section
201(ss)(1)(B)(ii);
``(iii) a specimen receptacle under section
201(ss)(1)(B)(iii);
``(iv) an in vitro clinical test, including
reagents used in such tests, intended for use
for testing donors, donations, and recipients
of blood, blood components, human cells,
tissues, cellular-based products, or tissue-
based products; or
``(v) a high-risk in vitro clinical test
without mitigating measures under section 587E,
which may include first-of-a-kind in vitro
clinical tests, home use in vitro clinical
tests, cross-referenced in vitro clinical
tests, and direct-to-consumer in vitro clinical
tests.
``(c) Public Meeting and Input.--
``(1) Public docket.--Not later than 30 days after the date
of enactment of the Verifying Accurate Leading-edge IVCT
Development Act of 2021, the Secretary shall establish a public
docket to receive comments concerning recommendations for
implementation of this section, including criteria and
procedures for subsections (e) through (j). The public docket
shall remain open for the duration of time that this section
remains in effect.
``(2) Public meeting.--Not later than 180 days after the
date of enactment of the Verifying Accurate Leading-edge IVCT
Development Act of 2021, the Secretary shall convene a public
meeting to which stakeholders from organizations representing
patients and consumers, academia, and the in vitro clinical
test industry are invited in order to discuss the technology
certification process including application requirements,
inspections, alignment with third-party accreditors, and the
definition of `technology' under section 587(17).
``(d) Regulations.--The Secretary shall issue regulations on
technology certification including describing criteria or procedures
relating to technology certification under this section, which shall be
subject to public comment for a minimum of 60 days from issuance prior
to finalizing such regulations after considering the comments received.
The regulation shall include an outline of the application and
recertification process, opportunities to meet with officials of the
Food and Drug Administration and plans to streamline inspections.
``(e) Application for Technology Certification.--
``(1) In general.--A person seeking a technology
certification order shall submit an application under this
subsection, which shall contain the information specified under
paragraph (2).
``(2) Content of application.--An application for
technology certification shall contain--
``(A) a statement identifying the scope of the
proposed technology certification, which shall be no
broader than a single technology intended to be offered
under the application;
``(B) information describing that the person
seeking a technology certification order is an eligible
person under subsection (b)(1);
``(C) information describing that the methods used
in, and the facilities and controls used for, the
development of eligible in vitro clinical tests covered
by the scope of the technology certification conform to
the applicable quality requirements of section 587J;
``(D) procedures for analytical validation,
including all procedures for validation, verification,
and acceptance criteria, and an explanation as to how
such procedures, when used, provide a reasonable
assurance of analytical validity of eligible in vitro
clinical tests within the proposed scope of the
technology certification order;
``(E) procedures for clinical validation, including
all procedures for validation, verification, and
acceptance criteria, and an explanation as to how such
procedures, when used, provide a reasonable assurance
of clinical validity of eligible in vitro clinical
tests within the proposed scope of the technology
certification order;
``(F) a submission under section 587I(b) for each
in vitro clinical test that the developer intends to
introduce into interstate commerce upon receiving a
technology certification order;
``(G) information concerning one or more
representative in vitro clinical tests, including--
``(i) a test within the scope of the
technology certification application with the
appropriate analytical complexity at the time
of the filing of the application under this
section to serve as the representative test and
validate and run within the developer's stated
scope;
``(ii) the information specified in
subsection (c) or (d) of section 587B, as
applicable, for the representative in vitro
clinical test or tests, including information
and data required pursuant to subsection
(c)(2)(H) of section 587B, unless the Secretary
determines that such information is not
necessary;
``(iii) an explanation of the choice of the
representative in vitro clinical test or tests
for the technology certification application
and how such test adequately demonstrates the
range of procedures that the developer includes
in the application under subparagraphs (C),
(D), (E), and (F); and
``(iv) a brief explanation of the ways in
which the procedures included in the
application under subparagraphs (C), (D), (E),
and (F) have been applied to the representative
in vitro clinical test or tests;
``(H) such other information as the Secretary may
determine necessary; and
``(I) a statement that the applicant believes to
the best of the applicant's knowledge that all data and
information submitted to the Secretary are truthful and
accurate and that no material fact has been omitted.
``(3) Reference to approved premarket application under
section 587b.--With respect to the content requirements in the
technology certification application described in paragraph
(2), a developer may incorporate by reference any content of an
application previously submitted by the developer and approved
under section 587B.
``(f) Action on an Application for Technology Certification.--
``(1) Secretary response.--
``(A) In general.--As promptly as practicable, and
no later than 90 days after receipt of an application
under subsection (c), the Secretary shall--
``(i) issue a technology certification
order granting the application, which shall
specify the scope of the technology
certification, if the Secretary finds that all
of the grounds in paragraph (3) are met; or
``(ii) deny the application if the
Secretary finds (and sets forth the basis of
such finding as part of or accompanying such
denial) that one or more grounds for granting
the application specified in paragraph (3) are
not met.
``(B) Extension.--The timeline described in
subparagraph (A) may be extended by mutual agreement
between the Secretary and the applicant.
``(2) Deficient applications.--
``(A) If, after receipt of an application under
this section, the Secretary determines that any portion
of such application is deficient, the Secretary, not
later than 60 days after receipt of such application,
shall provide to the applicant a description of such
deficiencies and identify the information required to
correct such deficiencies.
``(B) When responding to the deficiency letter, the
applicant may convert the application for technology
certification under subsection (c) into a premarket
application under section 587B.
``(3) Technology certification order.--The Secretary shall
grant a technology certification order under this section if,
on the basis of the information submitted to the Secretary as
part of the application and any other information with respect
to such applicant, the Secretary finds that--
``(A) in accordance with subsection (e)(2)(D),
there is a showing of reasonable assurance of
analytical validity for all eligible in vitro clinical
tests within the proposed scope of the technology
certification, as evidenced by the procedures for
analytical validation;
``(B) in accordance with subsection (e)(2)(E),
there is a showing of reasonable assurance of clinical
validity for eligible in vitro clinical tests within
the proposed scope of the technology certification, as
evidenced by the clinical program, including procedures
for clinical validation;
``(C) the methods used in, or the facilities or
controls used for, the development of eligible in vitro
clinical tests covered by the proposed scope of the
technology certification conform to the applicable
requirements of section 587J;
``(D) based on a fair evaluation of all material
facts, the applicant's proposed labeling and
advertising is not false or misleading in any
particular;
``(E) the application does not contain a false
statement of material fact;
``(F) there is a showing that the representative in
vitro clinical test or tests--
``(i) meet the applicable standard for such
order; and
``(ii) reasonably represent the range of
procedures for analytical validation and
clinical validation included in the
application, as applicable; and
``(G) the applicant permits authorized employees of
the Food and Drug Administration or persons accredited
under this Act an opportunity to inspect at a
reasonable time and in a reasonable manner the
facilities and all pertinent equipment, finished and
unfinished materials, containers, and labeling therein,
including all things (including records, files, papers,
and controls) bearing on whether an in vitro clinical
test is adulterated, misbranded, or otherwise in
violation of this Act, and permits such authorized
employees or persons accredited under this Act to view
and to copy and verify all records pertinent to the
application and the in vitro clinical test.
``(4) Effect of technology certification order.--An in
vitro clinical test or tests within the scope of a granted
technology certification order are cleared to be introduced
into interstate commerce.
``(5) Review of denials.--If the Secretary denies an
application for technology certification, including an
application for renewal under subsection (g), the Secretary
will provide a summary of deficiencies on which the Secretary
based its denial. An applicant whose application has been
denied may, by petition filed on or before the date that is 30
calendar days after the date upon which such applicant receives
notice of such denial, obtain review thereof in accordance with
section 587O.
``(g) Duration; Subsequent Submissions.--
``(1) Order duration.--A technology certification order
shall remain in effect until the earlier of--
``(A) the expiration of such technology
certification order under paragraph (2); or
``(B) the withdrawal of such technology
certification order under subsection (j).
``(2) Expiration.--
``(A) An initial technology certification order
issued under subsection (f)(3) shall expire 4 years
after the date that such order is issued, except that
if an application for renewal under paragraph (3) has
been received not later than 30 days prior to the
expiration of such order under this paragraph, such
order shall expire on the date on which the Secretary
has granted or denied the application for renewal. Any
such subsequent renewal of a technology certification
shall expire on such date specified by the Secretary
that is not later than 4 years after the date that such
technology certification order is issued.
``(B) In the event of expiration of technology
certification order, the clearance of tests introduced
into interstate commerce under such order prior to its
expiration pursuant to subsection (f)(3) remain in
effect.
``(3) Renewal.--
``(A) In general.--Any person previously granted a
technology certification order in effect may seek
renewal of such order provided that--
``(i) such person is an eligible person
under subsection (b)(1);
``(ii) the previously granted technology
certification order--
``(I) is not on temporary hold
under subsection (i); and
``(II) was not withdrawn under
subsection (j); and
``(iii) none of the information specified
in subsection (e)(2) has substantially changed,
except as described in supplements to orders
granted under paragraph (4).
``(B) Content.--An application for renewal under
this paragraph shall include information concerning one
or more representative in vitro clinical tests in
accordance with subsection (e)(2)(G), except that such
representative test or tests shall be different from
the representative test or tests relied upon as the
representative assay in any prior technology
certification, if applicable.
``(C) Process.--The Secretary's action on an
application for renewal of technology certification
under this paragraph shall be conducted, to the extent
practicable, in coordination with inspections conducted
under section 353 of the Public Health Service Act, if
applicable, and any order resulting from such renewal
application shall be treated as a technology
certification order for purposes of this subchapter.
``(4) Supplements and reports.--
``(A) Supplements.--Except as provided in
subparagraph (B), any person with a technology
certification order in effect may seek a supplement to
such order upon a change or changes to the information
provided in the application for technology
certification under subparagraphs (C), (D), and (E) of
subsection (e)(2), provided that--
``(i) such person is an eligible person
under subsection (b)(1); and
``(ii) such change does not expand the
scope of the technology certification, unless
the Secretary determines that such expansion is
appropriate.
A supplement to an order may contain only information
relevant to the change or changes. The Secretary's
action on a supplement shall be in accordance with
subsection (f), and any order resulting from such
supplement shall be treated as an amendment to a
technology certification order that is in effect.
``(B) Reports.--
``(i) In general.--If a change is made to
an in vitro clinical test or tests that is
beyond the scope of a technology certification
order but is made in order to address a
potential risk to public health by adding a new
specification or test method, the person may
immediately implement such change or changes
and shall report such changes or changes to the
Secretary within 30 days.
``(ii) Content.--Any report to the
Secretary under this subparagraph shall
include--
``(I) a summary of the relevant
change or changes;
``(II) the rationale for
implementing such change or changes;
``(III) a description of how the
change or changes were evaluated; and
``(IV) data indicating analytical
and clinical validity.
``(iii) Supplemental reports.--Upon review
of such report and a finding that the relevant
change or changes are inconsistent with the
standard specified under this subparagraph, the
Secretary may require a supplement under
subparagraph (A).
``(h) Maintenance Requirements.--For the duration of a technology
certification order, a holder of a technology certification order
shall--
``(1) use the procedures included in the relevant
application, supplement, or report under subsections (b) and
(e);
``(2) ensure compliance with any applicable mitigating
measures;
``(3) maintain, and provide to the Secretary upon request,
records related to any in vitro clinical test offered under the
technology certification order, where those records are
necessary to demonstrate compliance with applicable provisions
of this subchapter; and
``(4) comply with the listing requirements under section
587I for each in vitro clinical test offered under the
technology certification order.
``(i) Temporary Hold.--
``(1) In general.--Upon one or more findings under
paragraph (4) and after promptly notifying the developer of
such findings, the Secretary may issue a temporary hold
prohibiting any holder of a technology certification order from
introducing into interstate commerce an in vitro clinical test
that was not previously the subject of a notification under
section 587I. The temporary hold must identify the grounds for
the temporary hold under paragraph (4) and the rationale for
such finding, and may only remain in place until the Secretary
responds to a written request under paragraph (3).
``(2) Notification to the developer.--The Secretary shall
not place a temporary hold under this subsection unless the
Secretary has promptly notified the developer of such hold and
provided 30 calendar days for the developer to come into
compliance with or resolve the findings under paragraph (4).
``(3) Written requests.--Any written request to the
Secretary from the holder of a technology certification order
that a temporary hold under paragraph (1) be removed shall
receive a decision, in writing and specifying the reasons
therefore, within 90 days after receipt of such request. Any
such request shall include information to support the removal
of the temporary hold.
``(4) Grounds for temporary hold.--A temporary hold under
this subsection may be instated upon a finding or findings that
the holder of a technology certification order--
``(A) is not in compliance with any maintenance
requirements under subsection (h);
``(B) labels or advertises one or more in vitro
clinical tests with false or misleading claims; or
``(C) is no longer an eligible person under
subsection (b)(1).
``(j) Withdrawal.--The Secretary may, after due notice and
opportunity for informal hearing, issue an order withdrawing a
technology certification order if the Secretary finds that--
``(1) the application, supplement, or report under
subsection (e) or (g) contains materially false or misleading
information or fails to reveal a material fact;
``(2) such holder fails to correct materially false or
misleading labeling or advertising upon the request of the
Secretary;
``(3) in connection with a technology certification, the
holder provides materially false or misleading information to
the Secretary; or
``(4) the holder of such technology certification order
fails to correct the grounds for temporary hold within a
timeframe specified in the temporary hold order.
``(k) Reports to Congress.--
``(1) In general.--Not later than one year after date of
enactment of the Verifying Accurate Leading-edge IVCT
Development Act of 2021, and annually thereafter for the next 4
years, the Secretary shall submit to the Committee on Energy
and Commerce of the House of Representatives and the Committee
on Health, Education, Labor, and Pensions of the Senate, and
make publicly available, including through posting on the
website of the Food and Drug Administration, a report
containing the information described in paragraph (2).
``(2) Content.--
``(A) In general.--Each report under paragraph (1)
shall address, at a minimum--
``(i) the total number of applications for
technology certifications filed, granted,
withdrawn and denied;
``(ii) the total number of technology
certification orders put on temporary hold
under subsection (i) and the number of
technology certification orders withdrawn under
subsection (j);
``(iii) the types of technologies for which
technology certification orders were granted;
``(iv) the total number of developers,
including laboratories, with technology
certification orders in effect; and
``(v) the total number of approved tests
under section 587B that were reclassified and
granted a technology certification order under
this section.
``(B) Final report.--The fifth report submitted
under paragraph (1) shall include a summary of, and
responses to, comments raised in the meeting and
docket.
``(C) Performance reports.--The reports required
under this section may be issued with performance
reports as required under section 9 of the Verifying
Accurate Leading-edge IVCT Development Act of 2021.
``SEC. 587E. MITIGATING MEASURES.
``(a) Establishment of Mitigating Measures.--
``(1) Establishing, changing, or withdrawing.--
``(A) Establishment.--If the Secretary requires the
establishment of mitigating measures pursuant to clause
(i) or (ii) of section 587(15)(A) for any in vitro
clinical test, the Secretary may require such
mitigating measures for any other in vitro clinical
test with the same indications for use.
``(B) Process.--Notwithstanding subchapter II of
chapter 5 of title 5, United States Code, the Secretary
may--
``(i) establish, change, or withdraw
mitigating measures by--
``(I) publishing a proposed
administrative order in the Federal
Register;
``(II) providing an opportunity for
public comment for a period of not less
than 30 calendar days; and
``(III) after consideration of any
comments submitted, publishing a final
administrative order in the Federal
Register; and
``(ii) may establish mitigating measures
with respect to a category in a premarket
approval order or technology certification
order.
``(2) In vitro clinical tests previously approved, cleared,
or exempted as devices.--
``(A) In general.--Any special controls or
restrictions applicable to an in vitro clinical test
with the same indications for use pursuant to section
587(10) based on prior regulation as a device approved
under section 515, cleared or exempt under section
510(k), or classified under section 513(f)(2),
including any such special controls or restrictions
established during the period beginning on the date of
enactment of the Verifying Accurate Leading-edge IVCT
Development Act of 2021 and ending on the effective
date of such Act (as described in section 5(b) of such
Act)--
``(i) shall continue to apply to such
approved, cleared, or exempted in vitro
clinical test after such effective date; and
``(ii) are deemed to be mitigating measures
as of the effective date of such approval,
clearance, or exemption.
``(B) Changes.--The Secretary may establish,
change, or withdraw mitigating measures for such a test
or indications for use the procedures under paragraph
(1).
``(b) Documentation.--
``(1) Tests subject to premarket review.--The developer of
an in vitro clinical test subject to premarket review under
section 587B and to which mitigating measures apply shall--
``(A) in accordance with section 587B(c)(2)(G)(i),
submit documentation to the Secretary as part of the
application for the test under subsection (c) or (d) of
section 587B demonstrating that such mitigating
measures have been met;
``(B) if such application is approved, maintain
documentation demonstrating that such mitigating
measures continue to be met following a test
modification by the developer; and
``(C) after responding to any informal
communications from the Secretary, make such
documentation available to the Secretary upon request
or inspection.
``(2) Other tests.--The developer of an in vitro clinical
test that is marketed within the scope of a technology
certification order or other exemption from premarket review
under section 587B and to which mitigating measures apply
shall--
``(A) maintain documentation in accordance with the
applicable quality requirements under section 587J
demonstrating that such mitigating measures continue to
be met following a test modification by the developer;
``(B) after responding to any informal
communications from the Secretary, make such
documentation available to the Secretary upon request
or inspection; and
``(C) include in the performance summary for such
test a brief description of how such mitigating
measures are met, if applicable.
``(c) Mitigating Measures for Cross-Referenced Tests.--Not later
than 1 year after the implementation of the Verifying Accurate Leading-
edge IVCT Development Act of 2021, the Secretary shall issue mitigating
measures for cross-referenced tests.
``SEC. 587F. REGULATORY PATHWAY REDESIGNATION.
``(a) Technology Certification and Exemption Determinations.--
``(1) In general.--Based on new information, including the
establishment of mitigating measures under section 587E, and
after considering available evidence respecting tests with the
same indications for use pursuant to section 587(10), the
Secretary may, upon the initiative of the Secretary or upon
petition of an interested person--
``(A) revoke any exemption or requirement in effect
under this subchapter with respect to such indications
for use; or
``(B) determine that such indications for use are
eligible for technology certification in accordance
with section 587D(b)(2).
``(2) Process.--Any action under paragraph (1) shall be
made by publication of a notice of such proposed action on the
website of the Food and Drug Administration, the consideration
of comments to a public docket on such proposal, and
publication of a final action on such website within 60
calendar days of the close of the comment period posted to such
public docket, notwithstanding subchapter II of chapter 5 of
title 5, United States Code.
``(b) Revocation.--The Secretary may revoke any exemption with
respect to such test or indications for use pursuant to section
587(10), if--
``(1) new clinical information indicates that the exemption
of an in vitro clinical test or tests from premarket review
under section 587B or exemption under section 587A has a
reasonable probability of severe adverse health consequences,
including the absence, delay, or discontinuation of appropriate
medical treatment.
``(2) Process.--Any action under this subsection shall be
made by publication of a notice of such proposed action in the
Federal Register, consideration of comments to a public docket
on such proposal, and publication of a final notice in the
Federal Register, notwithstanding subchapter II of chapter 5 of
title 5, United States Code.
``SEC. 587G. ADVISORY COMMITTEES.
``(a) In General.--The Secretary may establish advisory committees
or use advisory committee panels of experts established before the date
of enactment of this section for the purposes of providing expert
scientific advice and making recommendations related to--
``(1) the approval of an application for an in vitro
clinical test submitted under this subchapter, including for
evaluating, as applicable, the analytical validity, clinical
validity, and safety of in vitro clinical tests;
``(2) the potential effectiveness of mitigating measures
for a determination on the applicable regulatory pathway under
section 587F or risk evaluation for an in vitro clinical test
or tests;
``(3) quality requirements under section 587J or applying
such requirements to in vitro clinical tests developed or
imported by developers; or
``(4) such other purposes as the Secretary determines
appropriate.
``(b) Appointments.--
``(1) Voting members.--The Secretary shall appoint to each
committee established under subsection (a), as voting members,
individuals who are qualified by training and experience to
evaluate in vitro clinical tests referred to the committee for
the purposes specified in subsection (a), including individuals
with, to the extent feasible, scientific expertise in the
development, manufacture, or utilization of such in vitro
clinical tests, laboratory operations, and the use of in vitro
clinical tests. The Secretary shall designate one member of
each committee to serve as chair.
``(2) Nonvoting members.--In addition to the individuals
appointed pursuant to paragraph (1), the Secretary shall
appoint to each committee established under subsection (a), as
nonvoting members--
``(A) a representative of consumer interests; and
``(B) a representative of interests of in vitro
clinical test developers not directly affected by the
matter to be brought before the committee.
``(3) Limitation.--No individual who is in the regular
full-time employee of the United States and engaged in the
administration of this Act may be a member of any advisory
committee established under subsection (a).
``(4) Education and training.--The Secretary shall, as
appropriate, provide education and training to each new
committee member before such member participates in a
committee's activities, including education regarding
requirements under this Act and related regulations of the
Secretary, and the administrative processes and procedures
related to committee meetings.
``(5) Meetings.--The Secretary shall ensure that scientific
advisory committees meet regularly and at appropriate intervals
so that any matter to be reviewed by such a committee can be
presented to the committee not more than 60 calendar days after
the matter is ready for such review. Meetings of the committee
may be held using electronic communication to convene the
meetings.
``(6) Compensation.--Members of an advisory committee
established under subsection (a), while attending meetings or
conferences or otherwise engaged in the business of the
advisory committee--
``(A) shall be entitled to receive compensation at
rates to be fixed by the Secretary, but not to exceed
the daily equivalent of the rate in effect for
positions classified above level GS-15 of the General
Schedule; and
``(B) may be allowed travel expenses as authorized
by section 5703 of title 5, United States Code, for
employees serving intermittently in the Government
service.
``(c) Guidance.--The Secretary may issue guidance on the policies
and procedures governing advisory committees established under
subsection (a).
``SEC. 587H. REQUEST FOR INFORMAL FEEDBACK.
``Before submitting a premarket application or technology
certification application for an in vitro clinical test--
``(1) the developer of the test may submit to the Secretary
a written request for a meeting, conference, or written
feedback to discuss and provide information relating to the
regulation of such in vitro clinical test which may include--
``(A) the submission process and the type and
amount of evidence expected to demonstrate the
applicable standard;
``(B) which regulatory pathway is appropriate for
an in vitro clinical test; and
``(C) an investigation plan for an in vitro
clinical test, including a clinical protocol; and
``(2) upon receipt of such a request, the Secretary shall--
``(A) within 60 calendar days after such receipt,
or within such time period as may be agreed to by the
developer, meet or confer with the developer submitting
the request; and
``(B) within 15 calendar days after such meeting or
conference, provide to the developer a written record
or response describing the issues discussed and
conclusions reached in the meeting or conference.
``SEC. 587I. REGISTRATION AND LISTING.
``(a) Registration of Establishments for In Vitro Clinical Tests.--
``(1) In general.--Each person described in subsection
(b)(1), or an accredited person under section 587P, acting on
behalf of such a person, shall--
``(A) during the period beginning on October 1 and
ending on December 31 of each year, register with the
Secretary the name of such person, places of business
of such person, all establishments engaged in the
activities specified under this paragraph, the
establishment registration number of each such
establishment, and a point of contact for each such
establishment, including an electronic point of
contact; and
``(B) submit an initial registration containing the
information required under subparagraph (A) not later
than--
``(i) the date of implementation of this
section if such establishment is engaged in any
activity described in subsection (b)(1) on the
date of enactment of this section, unless the
Secretary establishes by guidance a date later
than such implementation date for all or a
category of such establishments; or
``(ii) 30 days prior to engaging in any
activity described in subsection (b)(1) after
enactment of this section, if such
establishment is not engaged in any activity
described in this paragraph on the date of
enactment of this section.
``(2) Registration numbers.--The Secretary may assign a
registration number to any person or an establishment
registration number to any establishment registered in
accordance with this section. Registration information shall be
made publicly available by publication on the website
maintained by the Food and Drug Administration, in accordance
with subsection (d).
``(3) Inspection.--Each person or establishment that is
required to be registered with the Secretary under this section
shall be subject to inspection pursuant to section 704.
``(b) Listing Information for In Vitro Clinical Tests.--
``(1) In general.--Each person who--
``(A) is a developer, a contract manufacturer
(including contract packaging), contract sterilizer,
repackager, relabeler, or distributor of an in vitro
clinical test; and
``(B) introduces or proposes to begin the
introduction or delivery for introduction into
interstate commerce through an exemption under section
587A(f)(2)(b) or 587A(g) or through the filing of an
application under section 587B or 587D,
shall submit a listing to the Secretary containing the
information described in paragraph (2) in accordance with the
applicable schedule described under subsection (c). Such
listing shall be prepared in such form and manner as the
Secretary may specify in guidance. Listing information shall be
submitted through the comprehensive test information system in
accordance with section 587T, as appropriate.
``(2) Submissions.--Each developer submitting a listing
under paragraph (1) shall electronically submit to the
comprehensive test information system under section 587T the
following information for each in vitro clinical test for which
such person is a developer in the form and manner prescribed by
the Secretary:
``(A) Name of the establishment and its
establishment registration number.
``(B) Contact information for the official
correspondent for the listing.
``(C) Name (common name and trade name, if
applicable) of the in vitro clinical test and its test
listing number (when available).
``(D) CLIA certificate number for any laboratory
certified by the Secretary under section 353 of the
Public Health Service Act that meets the requirements
for performing high-complexity testing that is the
developer of the in vitro clinical test, and CLIA
certificate number for any laboratory under common
ownership that is performing the test developed by such
test developer.
``(E) Whether the in vitro clinical test is, as
applicable, offered as a test approved under section
587B, offered under a technology certification o, or
offered as an in vitro clinical test under section
587Arder issued under section 587D.
``(F) Indications for use information under section
587(10).
``(G) Brief narrative description of the in vitro
clinical test.
``(H) A brief summary of the analytical and
clinical performance of the in vitro clinical test, and
as applicable, the lot release criteria.
``(I) A brief description of conformance with any
applicable mitigating measures, restrictions, and
standards.
``(J) Representative labeling for the in vitro
clinical test, as appropriate.
``(K) A statement that the information submitted is
truthful and accurate.
``(3) Test listing number.--The Secretary may assign a test
listing number to each in vitro clinical test that is the
subject of a listing under this section. The process for
assigning test listing numbers may be established through
guidance, and may include the recognition of standards,
formats, or conventions developed by a third-party
organization.
``(4) Abbreviated listing.--A person who is not a developer
but is otherwise required to register pursuant to subsection
(a) shall submit an abbreviated listing to the Secretary
containing the information described in subparagraphs (A)
through (C) of paragraph (2), and the name of the developer.
The information shall be submitted in accordance with the
applicable schedule described under subsection (c). Such
abbreviated listing shall be prepared in such form and manner
as the Secretary may specify in guidance. Listing information
shall be submitted to the comprehensive test information system
in accordance with section 587T, as appropriate.
``(5) Grandfathered tests.--A developer of an in vitro
clinical test developer offering a test that is grandfathered
under section 587A(c) shall submit listing information required
under subparagraphs (A) through (K) of paragraph (2).
``(6) Low-risk tests.--A developer of a low risk in vitro
clinical test shall notify and submit listing information to
the Secretary within one year of offering such test for
clinical use.
``(7) Exempt tests.--A developer of an in vitro clinical
test who introduces or proposes to begin the introduction or
delivery for introduction into interstate commerce pursuant to
an exemption under section 587A may submit listing information
under this subsection.
``(c) Timelines for Submission.--
``(1) In general.--The timelines for submission of
registration and listing under subsections (a) and (b) are as
follows:
``(A) For an in vitro clinical test that was listed
as a device under section 510(j) prior to the date of
enactment of this section, a person shall maintain a
device listing under section 510 until such time as the
system for submitting the notification information
required under subsection (b) becomes available and
thereafter shall submit the notification information no
later than 1 year after the system for submitting the
notification under this section becomes available.
``(B) For an in vitro clinical test that is subject
to the grandfathering provisions of section 587A(c), a
person shall submit the listing information required
under subsection (b)(5) no later than 1 year after the
system for submitting the notification under this
section becomes available.
``(C) For an in vitro clinical test that is not
described in subparagraph (A) or (B), a person shall
submit the required notification information prior to
offering, introducing, or marketing the in vitro
clinical test as follows:
``(i) For an in vitro clinical test that is
not exempt from premarket approval under
section 587B, a person shall submit the
required listing information no later than 30
business days after the date of approval of the
premarket approval application.
``(ii) For a developer who has received a
technology certification order under section
587D, a person shall submit the required
listing information at least 30 business days
after receiving such technology certification
order.
``(2) Updates.--
``(A) Updates after changes.--Each developer
required to submit listing information under this
section shall update such information within 10
business days of any change that causes any previously
notified information to be inaccurate or incomplete.
``(B) Annual updates.--Each developer required to
submit listing information under this section shall
update its information annually during the period
beginning on October 1 and ending on December 31 of
each year as a component of the annual report submitted
under sections 587B and 587D.
``(d) Public Availability of Notification Information.--
``(1) In general.--Notification information submitted
pursuant to this section shall be made publicly available on
the website of the Food and Drug Administration in accordance
with paragraph (3).
``(2) Confidentiality.--Notification information for an in
vitro clinical test that is subject to premarket approval or
technical certification shall remain confidential until such
date as the in vitro clinical test receives the applicable
premarket approval or the developer receives a technology
certification order.
``(3) Exceptions from public availability requirements.--
The registration and listing information requirements described
in subsections (a) and (b) shall not apply to the extent the
Secretary determines that such information relates to--
``(A) trade secret or commercial confidential
information; or
``(B) national security or countermeasures or is
restricted from disclosure pursuant to another
provision of law.
``(e) Submission of Information by Accredited Persons.--If agreed
upon by the developer, the information required under this section may
be submitted by an accredited person under section 587P.
``SEC. 587J. TEST DESIGN AND QUALITY REQUIREMENTS.
``(a) Applicability.--
``(1) In general.--Each developer and each other person
required to register under section 587I(b)(1) shall establish
and maintain quality requirements in accordance with the
applicable requirements set forth in subsection (b), except as
provided in section 587A.
``(2) Certified laboratory requirements.--A developer that
operates a clinical laboratory certified by the Secretary under
section 353 of the Public Health Service Act that--
``(A) meets the requirements for performing high-
complexity testing;
``(B)(i) develops an vitro clinical test or
indications for use; or
``(ii) modifies another developer's in vitro
clinical test in that certified laboratory in a manner
described in section 587(6)(C); and
``(C) develops an in vitro clinical test or
indications for use that are for use only within that
certified laboratory or within another certified
laboratory with common ownership,
shall establish and maintain quality requirements that comply
with the requirements set forth in subsection (b)(2).
``(3) Applicability for certain in vitro clinical tests.--
The applicable requirements set forth in subsection (b)(1)
shall apply to any instrument, specimen receptacle, or
component or part that is developed for use by a clinical
laboratory to which paragraph (2) applies.
``(4) Regulations.--In promulgating regulations under this
section, the Secretary shall consider whether and to what
extent international harmonization is appropriate.
``(b) Quality Requirements.--
``(1) Quality requirements for laboratories without clia
certification to conduct high-complexity tests.--The quality
requirements applicable under this section shall--
``(A) avoid duplication of regulations under
section 353 of the Public Health Service Act;
``(B) apply only to the development, validation,
production, preparation, propagation, or assembly
related to the design and associated manufacture and
distribution of an in vitro clinical test offered under
this subchapter;
``(C) not apply with respect to laboratory
operations; and
``(D) shall include the following, subject to
paragraphs (2) and (3)--
``(i) management responsibility;
``(ii) quality audits;
``(iii) personnel;
``(iv) design controls;
``(v) document controls;
``(vi) purchasing controls;
``(vii) identification and traceability;
``(viii) production and process controls;
``(ix) acceptance activities;
``(x) nonconforming product;
``(xi) corrective and preventive action;
``(xii) labeling and packaging controls;
``(xiii) handling, storage, distribution,
and installation;
``(xiv) records;
``(xv) servicing; and
``(xvi) statistical techniques.
``(2) Quality requirements for laboratories certified to
conduct high-complexity tests.--Quality requirements applicable
to the in vitro clinical tests and developers described in
subsection (a)(2) shall--
``(A) avoid duplication of regulations under
section 353 of the Public Health Service Act; and
``(B) consist of, as directed related to the design
and development--
``(i) design controls;
``(ii) purchasing controls;
``(iii) acceptance activities;
``(iv) corrective and preventative action;
and
``(v) records.
``(3) Quality requirements for certain laboratories
distributing in vitro clinical tests or test protocols within
organizations or public health networks.--
``(A) In general.--Quality requirements applicable
to the developer who is distributing in vitro clinical
test distributed as described in subparagraph (B) shall
consist of the following:
``(i) The requirements in paragraph (2).
``(ii) The labeling requirements in
paragraph (1)(C)(xii).
``(iii) The requirement to maintain records
of the laboratories to which the in vitro
clinical test or test protocol is distributed.
``(B) Distributing laboratory.--Subparagraph (A)
shall apply to developers that meet the following
conditions:
``(i) The laboratory distributing the test
protocol is certified by the Secretary under
section 353 of the Public Health Service Act
and meets the requirements for performing high-
complexity testing.
``(ii) The laboratory develops its own in
vitro clinical test or modifies another
developer's in vitro clinical test in a manner
described in section 587(6)(C).
``(iii) The laboratory distributes the in
vitro clinical test or test protocol for such
test only to another laboratory that--
``(I) is certified by the Secretary
under section 353 of the Public Health
Service Act and meets the requirements
for performing high-complexity testing;
``(II) is within the same corporate
organization and having common
ownership by the same parent
corporation; or as applicable, is a
laboratory within a public health
laboratory network coordinated or
managed by the Centers for Disease
Control and Prevention; and
``(III) implements the test
protocol without further modification.
``(c) Regulations.--In implementing quality requirements for test
developers under this section, the Secretary shall--
``(1) for purposes of facilitating international
harmonization, consider whether the developer participates in
an audit program in which the United States participates or the
United States recognizes or conforms with standards recognized
by the Secretary; and
``(2) ensure a least burdensome approach described in
section 587B(j) by leveraging, to the extent applicable, the
quality assurance requirements applicable to developers
certified by the Secretary under section 353 of the Public
Health Service Act.
``SEC. 587K. LABELING REQUIREMENTS.
``(a) In General.--An in vitro clinical test shall bear or be
accompanied by labeling, and a label as applicable, that meet the
requirements set forth in subsections (b) and (c), unless such test is
exempt as specified in subsection (d) or (e).
``(b) Labels.--
``(1) In general.--The label of an in vitro clinical test
shall meet the requirements set forth in paragraph (2), except
this requirement shall not apply to an in vitro clinical test
that--
``(A) consists solely of a test protocol; or
``(B) is developed, manufactured, and used solely
within a single laboratory certified by the Secretary
under section 353 of the Public Health Service Act that
meets the requirements for performing high-complexity
testing.
``(2) Regulations.--The label of an in vitro clinical test
shall state the name and place of business of its developer and
meet the requirements set forth in regulations promulgated
under this section.
``(c) Labeling.--
``(1) In general.--Labeling accompanying an in vitro
clinical test, including labeling in the form of a package
insert, standalone laboratory reference document, or other
similar document except the labeling specified in paragraph
(2), shall include adequate directions for use and shall meet
the requirements set forth in regulations promulgated under
this section, except as provided in subsection (d) or (e).
``(2) Content.--
``(A) In general.--Labeling accompanying an in
vitro clinical test that is in the form of a test
report template or ordering information shall include--
``(i) the test listing number that was
provided to the developer at the time of
listing;
``(ii) instructions for how and where to
report an adverse event under section 587L;
``(iii) instructions for how and where to
access the performance summary data displayed
in the listing database for the test;
``(iv) the intended use of the in vitro
clinical test; and
``(v) any warnings, contraindications, or
limitations.
``(B) Public availability of information.--The
Secretary shall make all of the information described
in subparagraph (A) with respect to each in vitro
clinical test available to the public, as applicable,
in accordance with section 587T, except to the extent
that the Secretary determines that such information
is--
``(i) trade secret or commercial
confidential information; or
``(ii) national security or countermeasures
or is restricted from disclosure pursuant to
another provision of law.
``(3) Additional requirements.--Labeling for an in vitro
clinical test used for immunohematology testing shall meet the
applicable requirements set forth in part 660 of title 21, Code
of Federal Regulations (or any successor regulations), related
to the labeling of blood grouping reagents, reagent red blood
cells, and anti-human globulin.
``(d) Exemptions and Alternative Requirements.--
``(1) In general.--
``(A) In general.--With respect to an in vitro
clinical test that meets the criteria of subparagraph
(B), the `state in one place' regulations under section
809.10(b) of title 21 of the Code of Federal
Regulations (or any successor regulations) may be
satisfied by the laboratory posting such information on
its website or in multiple documents, if such documents
are maintained and accessible in one place.
``(B) Applicable tests.--An in vitro clinical test
meets the criteria of this subparagraph if such test
is--
``(i) designed and manufactured by a
laboratory certified by the Secretary under
section 353 of the Public Health Service Act
that meets the requirements for performing
high-complexity testing; and
``(ii) performed in the same laboratory in
which it was developed or by another such
laboratory certified by the Secretary under
section 353 of the Public Health Service Act
that meets the requirements for performing high
complexity testing and is under common
ownership with the laboratory that designed and
manufactured the test.
``(2) Test instrument labeling.--The labeling for an
instrument is not required to bear the information indicated in
paragraphs (3), (4), (5), (7), (8), (9), (10), (11), (12), and
(13) of section 809.10(b) of title 21 of the Code of Federal
Regulations (or any successor regulations).
``(3) Reagent labeling.--For purposes of compliance with
subsection (c)(1), the labeling for a reagent intended for use
as a replacement in an in vitro clinical test may be limited to
that information necessary to identify the reagent adequately
and to describe its proper use in the system.
``(4) Lab research or investigational use.--A shipment or
other delivery of an in vitro clinical test for research or
investigational use pursuant to section 587A(m) shall be exempt
from the labeling requirements of subsections (b) and (c)(1)
and from any standard promulgated through regulations, except
as required under section 353 of the Public Health Service Act
or section 587R of this Act.
``(5) General purpose laboratory reagents.--The labeling of
general purpose laboratory reagents (such as hydrochloric acid)
whose uses are generally known by persons trained in their use
need not bear the directions for use required by subsections
(b) and (c)(1).
``(6) Analyte specific reagents.--The labeling for analyte
specific reagents shall bear the following statement: `This
product is intended solely for further development of an in
vitro clinical test and is exempt from most FDA regulation.
This product must be evaluated by the in vitro clinical test
developer in accordance with applicable requirements.'. If the
labeling of an analyte specific reagent bears the statement set
forth in this paragraph, it need not bear the information
required by subsection (c)(1).
``(7) Over-the-counter test sample collection systems
labeling.--The labeling for over-the-counter test sample
collection systems for drugs of abuse testing shall bear the
name and place of business of the developer included in the
registration listing under section 587I, in language
appropriate for the intended users.
``(e) Tests in the Strategic National Stockpile.--
``(1) In general.--The Secretary may grant an exception or
alternative to any provision listed in this section, unless
explicitly required by a statutory provision outside this
subchapter, for specified lots, batches, or other units of an
in vitro clinical test, if the Secretary determines that
compliance with such labeling requirement could adversely
affect the safety, effectiveness, or availability of such
products that are or will be included in the Strategic National
Stockpile under section 319F-2 of the Public Health Service
Act.
``(2) Regulations.--The Secretary may issue regulations
amending section 809.11 of title 21 of the Code of Federal
Regulations or any successor regulation to apply in full or in
part to in vitro clinical tests and in vitro clinical test
developers.
``(f) Guidance.--The Secretary may, in collaboration with
developers, issue guidance on standardized, general content and format
for in vitro clinical test labeling to help ensure compliance with
applicable requirements in this subsection.
``SEC. 587L. ADVERSE EVENT REPORTING.
``(a) Applicability.--
``(1) In general.--Each in vitro clinical test developer
shall establish and maintain a system for reporting adverse
events in accordance with subsection (b), except as provided in
section 587A.
``(2) Regulations.--The Secretary shall promulgate
regulations to implement this section, including information
necessary to be reported to ensure the analytical and clinical
validity of in vitro clinical tests, and the safety of articles
for taking or deriving specimens from the human body.
``(b) Adverse Event Reporting Requirements.--Each developer shall
report to the Secretary whenever information that reasonably suggests
that one of the developer's in vitro clinical tests is associated with
an adverse event becomes known to the developer.
``(c) Reports.--Reports required under this section shall be
submitted as follows:
``(1) An individual adverse event report shall be submitted
for the following events not later than--
``(A) 5 calendar days after an in vitro clinical
test developer receives or otherwise becomes aware of
information that reasonably suggests the adverse event
involves a patient death; or
``(B) 5 calendar days after an in vitro clinical
test developer receives or otherwise becomes aware of
information that reasonably suggests the event presents
an imminent threat to public health.
``(2) Quarterly reports shall be submitted for all other
adverse events, if any, and no later than the end of the
quarter following the quarter in which the adverse event
information was received by the in vitro clinical test
developer.
``(d) Definitions.--In this section--
``(1) the term `adverse event'--
``(A) means--
``(i) death of, or serious injury to, a
specific patient or user for which it is
reasonably believed that an in vitro clinical
test error contributed to such death or serious
injury; or
``(ii) an in vitro clinical test error that
may have reasonable likelihood to cause serious
injury or death; and
``(B) excludes laboratory errors that are subject
to the requirements of section 353 of the Public Health
Service Act and corrective or preventive actions to
prevent such errors;
``(2) the term `in vitro clinical test error'--
``(A) means a failure in an in vitro clinical test
to meet the analytical or clinical validity standard or
otherwise perform as intended by the developer; and
``(B) includes an inaccurate false result that
reaches a health care provider, patient, or consumer,
except that such term excludes any such event or error
related to laboratory operations pursuant to section
353 of the Public Health Service Act; and
``(3) the term `serious injury' means--
``(A) a significant delay in a critical diagnosis
or causing the absence, delay, or discontinuation of
critical medical treatment or that irreversibly or
seriously and negatively alters the course of the
disease or condition; or
``(B) an injury that--
``(i) is life threatening;
``(ii) results in permanent impairment of a
body function or permanent damage to a body
structure; or
``(iii) necessitates medical or surgical
intervention to preclude permanent impairment
of a body function or permanent damage to a
body structure.
``SEC. 587M. CORRECTIONS AND REMOVALS.
``(a) In General.--The Secretary shall promulgate regulations to
implement this section, including information necessary to be reported
to ensure the analytical and clinical validity of in vitro clinical
tests, and the safety of specimen receptacles.
``(b) Reports of Removals and Corrections.--
``(1) In general.--Each in vitro clinical test developer or
importer shall report to the Secretary any correction or
removal of an in vitro clinical test undertaken by such
developer or importer if the removal or correction was
undertaken--
``(A) to reduce the risk to health posed by the in
vitro clinical test; or
``(B) to remedy a violation of this Act caused by
the in vitro clinical test which may present a risk to
health.
``(2) Exception.--No report of the correction or removal of
an in vitro clinical test is required under paragraph (1) if a
report of the correction or removal is required under, and has
been submitted under, section 587L.
``(c) Timing.--A developer or importer shall submit any report
required under this subsection to the Secretary within 15 business days
of initiating such correction or removal.
``(d) Recordkeeping.--A developer or importer of an in vitro
clinical test who undertakes a correction or removal of an in vitro
clinical test which is not required to be reported under this
subsection shall keep a record of such correction or removal.
``(e) Recall Communications.--Upon the voluntary reporting of a
correction or removal by the developer--
``(1) the Secretary shall classify such correction or
removal under this section within 15 calendar days; and
``(2) not later than 45 calendar days after the developer
or other responsible party notifies the Secretary that it has
completed a recall action, the Secretary shall provide the
developer or other responsible party with a written statement
closing the recall action or stating the reasons the Secretary
cannot close the recall at that time.
``(f) Limitation.--The developer is not required to report a
correction or removal of an in vitro clinical test based solely on an
adverse event report under section 587L that captures an error within
the approved performance standards for such test.
``(g) Definitions.--For purposes of this section--
``(1) the term `correction' means the repair, modification,
adjustment, relabeling, destruction, or inspection (including
patient monitoring) of an in vitro clinical test without its
physical removal from its point of use to another location, and
does not include routine servicing; and
``(2) the term `removal' means the physical removal of an
in vitro clinical test from its point of use to another
location for repair, modification, adjustment, relabeling,
destruction, or inspection, and does not include routine
servicing.
``SEC. 587N. RESTRICTED IN VITRO CLINICAL TESTS.
``(a) Applicability.--
``(1) In general.--The Secretary, in issuing an approval of
an in vitro clinical test under section 587B of a category
described in paragraph (3) may require that such test be
restricted to sale, distribution, or use upon such conditions
as the Secretary may prescribe under paragraph (2).
``(2) Conditions prescribed by the secretary.--The
conditions prescribed by the Secretary under this paragraph,
with respect to an in vitro clinical test described in
paragraph (3), are those conditions which the Secretary
determines due to the potentiality for harmful effect of such
test (including any resulting absence, delay, or
discontinuation of appropriate medical treatment), are
necessary to assure the analytical or clinical validity of the
test, or the safety of a specimen receptacle.
``(3) In vitro clinical tests subject to restrictions.--The
restrictions authorized under this section may be applied by
the Secretary to any high-risk in vitro clinical test,
prescription home-use in vitro clinical test, direct-to-
consumer in vitro clinical test, or over-the-counter in vitro
clinical test.
``(b) Labeling and Advertising of a Restricted In Vitro Clinical
Test.--The label, labeling, and advertising of an in vitro clinical
test to which restrictions apply under subsection (a) shall bear such
appropriate statements of the restrictions as the Secretary may
prescribe in the approval, provisional approval, technology
certification, or regulation, as applicable.
``(c) Requirements Prior to Enactment.--An in vitro clinical test
that was offered, sold, or distributed as a restricted device prior to
the enactment date of this subchapter shall continue to comply with the
applicable restrictions under section 515 or section 520(e) until the
effective date of restrictions issued under subsection (a).
``SEC. 587O. APPEALS.
``(a) Significant Decision.--
``(1) In general.--The Secretary shall provide a
substantive summary of the scientific and regulatory rationale
for any significant decision of the Center for Devices and
Radiological Health regarding submission of an application for,
or a review of, an in vitro clinical test under section 587B or
section 587D or regarding an exemption under section 587A,
including documentation of significant controversies or
differences of opinion and the resolution of such controversies
or differences of opinion.
``(2) Provision of documentation.--Upon request, the
Secretary shall furnish a substantive summary described in
paragraph (1) to the person who has made, or is seeking to
make, a submission described in such paragraph.
``(3) Application of least burdensome requirements.--The
substantive summary required under this subsection shall
include a brief statement regarding how the least burdensome
requirements were considered and applied consistent with
section 587B(j), as applicable.
``(b) Review of Significant Decisions.--
``(1) Request for supervisory review of significant
decision.--Any person may request a supervisory review of the
significant decision described in subsection (a)(1). Such
review may be conducted at the next supervisory level or higher
above the agency official who made the significant decision.
``(2) Submission of request.--A person requesting a
supervisory review under paragraph (1) shall submit such
request to the Secretary not later than 30 days after the
decision for which the review is requested and shall indicate
in the request whether such person seeks an in-person meeting
or a teleconference review.
``(3) Timeframe.--The Secretary shall schedule an in-person
or teleconference review, if so requested, not later than 30
days after such request is made. The Secretary shall issue a
decision to the person requesting a review under this
subsection not later than 45 days after the request is made
under paragraph (1), or, in the case of a person who requests
an in-person meeting or teleconference, 30 days after such
meeting or teleconference.
``(c) Advisory Panels.--The process established under subsection
(a) shall permit the appellant to request review by an advisory
committee established under section 513 or 587G. The Secretary shall
provide a response to an appellant under this subsection not later than
45 days after the requested advisory committee is convened.
``SEC. 587P. ACCREDITED PERSONS.
``(a) In General.--
``(1) Review of applications.--
``(A) Accreditation for application review.--
Subject to subparagraph (C), during the period
beginning on the date of enactment of the Verifying
Accurate Leading-edge IVCT Development Act of 2021 and
ending 2 years after the date of enactment of such Act,
the Secretary shall accredit persons for any of the
following purposes:
``(i) Reviewing applications for premarket
approval under section 587B and applications
for technology certification under section
587D.
``(ii) Making recommendations to the
Secretary with respect to an approval of an
application under section 587B or issuance of a
technology certification order under section
587D.
``(B) Requirement regarding review
recommendations.--
``(i) In general.--In making a
recommendation to the Secretary under this
section, an accredited person shall notify the
Secretary in writing of the reasons for the
recommendation concerning the application.
``(ii) Time period for review.--Not later
than 30 calendar days after the date on which
the Secretary is notified of a recommendation
under this section with respect to an
application for premarket approval or
technology certification, the Secretary shall
make a determination with respect to the
application.
``(C) Lack of applications within 2-year
timeframe.--If the Secretary does not receive
applications from persons that meet the criteria under
subsection (c) within such period, the Secretary--
``(i) may accredit persons under this
paragraph after the 2-year period described in
subparagraph (A); and
``(ii) shall issue a public notice on the
website of the Food and Drug Administration
calling for applications for such
accreditation.
``(2) Inspections.--
``(A) Accreditation for inspections.--Subject to
subparagraph (B), during the period beginning on the
date of enactment of the Verifying Accurate Leading-
edge IVCT Development Act of 2021 and ending 2 years
after the date of enactment of such Act, the Secretary
shall accredit persons for the purpose of conducting
inspections of in vitro clinical test developers and
other persons required to register pursuant to section
587I.
``(B) Lack of applications within 2-year
timeframe.--If no persons who meet the criteria for
such accreditation apply during the 2-year period
described in subparagraph (A), the Secretary--
``(i) may accredit persons under this
subparagraph after such period; and
``(ii) shall issue a public notice on the
website of the Food and Drug Administration
calling for applications for such
accreditation.
``(C) Effect of accreditation.--
``(i) In general.--Persons accredited under
subparagraph (A) to conduct inspections, when
conducting such inspections, shall record in
writing their specific observations and shall
present their observations to the designated
representative of the inspected establishment.
``(ii) Inspection report requirements.--
Each person accredited under this paragraph
shall prepare and submit to the Secretary an
inspection report in a form and manner
designated by the Secretary for conducting
inspections, taking into consideration the
goals of international harmonization of quality
systems standards. Any official classification
of the inspection shall be determined by the
Secretary. Any statement or representation made
by an employee or agent of an establishment to
a person accredited to conduct inspections
shall be subject to section 1001 of title 18,
United States Code.
``(D) Savings clause.--Nothing in this section
affects the authority of the Secretary to inspect any
in vitro clinical test developer or other person
registered under section 587I.
``(E) Inspection limitations.--The Secretary shall
ensure that inspections carried out under this section
are not duplicative of inspections carried out under
section 353 of the Public Health Service Act.
Inspections under this section shall be limited to the
data and information necessary--
``(i) for routine surveillance activities
associated with applications under sections
587B and 587D; or
``(ii) to meet the requirements to receive
premarket approval under section 587B or a
technology certification order under section
587D, as applicable.
``(b) Accreditation.--
``(1) Accreditation program.--
``(A) In general.--The Secretary may provide for
accreditation under this section through programs
administered by the Food and Drug Administration, by
other non-Federal government agencies, or by qualified
nongovernmental organizations. A person may be
accredited for the review of both applications
submitted under sections 587B and 587D as described in
subsection (a)(1)(A) and to conduct inspection
activities under subsection (a)(2)(A), or for a subset
of such review or activities.
``(B) Eligible persons.--Not later than 180 days
after the date of enactment of the Verifying Accurate
Leading-edge IVCT Development Act of 2021, the
Secretary shall issue draft guidance on the criteria
that the Secretary will use to accredit or deny
accreditation to a person who requests such
accreditation under subsection (a), and not later than
one year after the close of the comment period for the
draft guidance issued in this section, issue final
guidance.
``(C) Requirements.--
``(i) In general.--The Secretary shall not
accredit or maintain accreditation for a person
unless such person meets the minimum
qualifications required under subsection (c).
``(ii) Scope of accreditation.--The
accreditation of a person under this section
shall specify the particular activities under
subsection (a) for which such person is
accredited.
``(D) Public list.--The Secretary shall publish on
the website of the Food and Drug Administration a list
of persons who are accredited under this section. Such
list shall be updated on at least a monthly basis. The
list shall specify the particular activity or
activities under this section for which the person is
accredited.
``(2) Accreditation process.--
``(A) Accreditation process guidance.--The
Secretary shall--
``(i) not later than 180 days after the
date of enactment of the Verifying Accurate
Leading-edge IVCT Development Act of 2021,
issue draft guidance specifying the process for
submitting a request for each type of
accreditation and reaccreditation under this
section, including the form and content of
information to be submitted in such a request;
and
``(ii) not later than 1 year after the
close of the comment period for the draft
guidance, issue final guidance.
``(B) Response to request.--The Secretary shall
respond to a request for accreditation or
reaccreditation within 60 calendar days of the receipt
of the request. The Secretary's response may be to
accredit or reaccredit the person, to deny
accreditation, or to request additional information in
support of the request. If the Secretary requests
additional information, the Secretary shall respond
within 60 calendar days of receipt of such additional
information to accredit or deny the accreditation.
``(C) Type of accreditation.--The accreditation or
reaccreditation of a person shall specify the
particular activity or activities under subsection (a)
for which such person is accredited, and shall include
any limitation to certain eligible in vitro clinical
tests.
``(D) Audit.--The Secretary may audit the
performance of persons accredited under this section
for purposes of ensuring that such persons continue to
meet the published criteria for accreditation, and may
modify the scope or particular activities for which a
person is accredited if the Secretary determines that
such person fails to meet one or more criteria for
accreditation.
``(E) Suspension or withdrawal.--The Secretary may
suspend or withdraw accreditation of any person
accredited under this section, after providing notice
and an opportunity for an informal hearing, when such
person is substantially not in compliance with the
requirements of this section or the published criteria
for accreditation, or poses a threat to public health,
or fails to act in a manner that is consistent with the
purposes of this section.
``(F) Reaccreditation.--Accredited persons may be
initially accredited for up to 4 years. After
expiration of such initial period, persons may be
reaccredited for unlimited additional 4-year periods,
as determined by the Secretary.
``(c) Qualifications of Accredited Persons.--
``(1) Eligibility.--An accredited person, at a minimum,
shall--
``(A) not be an employee of the Federal Government;
``(B) not engage in the activities of a developer,
as defined in section 587(7);
``(C) not be a person required to register under
section 587I, unless such person has established
sufficient processes and protocols to separate
activities to develop in vitro clinical tests and the
activities for which such person would be accredited
under subsection (a) and discloses applicable
information under this section;
``(D) not be owned or controlled by, and shall have
no organizational, material or financial affiliation
with, an in vitro clinical test developer or other
person required to register under section 587I;
``(E) be a legally constituted entity permitted to
conduct the activities for which it seeks
accreditation;
``(F) ensure that the operations of such person are
in accordance with generally accepted professional and
ethical business practices; and
``(G) include in its request for accreditation a
commitment to, at the time of accreditation and at any
time it is performing activities pursuant to this
section--
``(i) certify that the information reported
to the Secretary accurately reflects the data
or protocol reviewed, and the documented
inspection findings, as applicable;
``(ii) limit work to that for which
competence and capacity are available;
``(iii) treat information received or
learned, records, reports, and recommendations
as proprietary information of the person
submitting such information; and
``(iv) in conducting the activities for
which the person is accredited in respect to a
particular in vitro clinical test, protect
against the use of any employee or consultant
who has a financial conflict of interest
regarding that in vitro clinical test.
``(2) Waiver.--The Secretary may waive any requirements in
subparagraph (A), (B), (C), or (D) of paragraph (1) upon making
a determination that such person has implemented other
appropriate controls sufficient to ensure a competent and
impartial review.
``(d) Compensation of Accredited Persons.--
``(1) In general.--Compensation of an accredited person who
reviews an application for premarket approval submitted under
section 587B or an application for technical certification
submitted under section 587D shall be determined by agreement
between the accredited person and the person who engages the
services of the accredited person, and shall be paid by the
person who engages such services.
``(2) Inspection accreditation.--Compensation of an
accredited person who is conducting an inspection under section
704 shall be determined by agreement between the accredited
person and the person who engages the services of the
accredited person, and shall be paid by the person who engages
such services.
``(e) Cooperative Agreements.--The Secretary is authorized to enter
into cooperative arrangements with officials of foreign countries to
ensure that adequate and effective means are available for purposes of
determining, from time to time, whether in vitro clinical tests
intended for use in the United States by a person whose facility is
located outside the United States shall be refused admission on any of
the grounds set forth in section 801(a).
``(f) Information Sharing Agreements.--An accredited person may
enter into an agreement with a test developer to provide information to
the comprehensive test information system under section 587T, including
any requirements under section 587I.
``SEC. 587Q. RECOGNIZED STANDARDS.
``(a) In General.--The Secretary may by order establish performance
standards for an in vitro clinical test or tests with the same
indication for use to provide reasonable assurance of the analytical
validity, clinical validity, or as applicable safety, of that in vitro
clinical test or tests with the same indications for use.
``(b) Other Standards.--The Secretary may recognize all or part of
appropriate standards established by nationally or internationally
recognized standard development organizations for which a person may
submit a declaration of conformity in order to meet a requirement under
this subchapter to which that standard is applicable. In recognizing a
standard, any person requesting recognition of a standard or seeking to
use a recognized standard, the Secretary shall follow the processes and
requirements, in accordance with section 514(c). Standards for in vitro
diagnostic devices previously recognized under section 514(c) shall be
considered recognized standards under this section. The application of
any such consensus standard shall only apply prospectively. The
Secretary shall issue guidance establishing the criteria and process
for such recognition and adoption.
``(c) Order Process.--In establishing a standard under subsection
(a), the Secretary shall issue a draft order proposing to establish a
standard and shall provide for a comment period of not less than 60
calendar days. The Secretary may seek the recommendation of an advisory
committee under section 587G concerning a proposed standard either
prior to or after issuance of a proposed order. After considering the
comments and within 90 days of the close of the comment period, the
Secretary shall issue a final order adopting the proposed standard,
adopting a modification of the proposed standard or terminating the
proceeding.
``(d) Amendment Process.--The procedures established in this
section or in guidance issued under this section shall apply to
amendment of an existing standard.
``SEC. 587R. INVESTIGATIONAL USE.
``(a) In General.--Except as provided in subsection (c), an in
vitro clinical test for investigational use shall be exempt from the
requirements of this subchapter other than sections 587A, 587O, and
587U.
``(b) Regulations.--Not later than 2 years after the date of
enactment of the Verifying Accurate Leading-edge IVCT Development Act
of 2021, the Secretary shall promulgate regulations to implement this
section.
``(c) Application for Investigational Use.--
``(1) In general.--The following shall apply with respect
to in vitro clinical tests for investigational use:
``(A) Streamlining applications submitted under
this section.--Requirements with respect to such tests
shall be completed in accordance with current, at the
time of submitting the application, investigational use
requirements for institutional review boards and
current processes for any analytical or clinical
validation.
``(B) Variation.--The requirements in the
regulations promulgated under this section shall take
into account variations based on--
``(i) the scope and duration of clinical
testing to be conducted under investigation
that is the subject of such application;
``(ii) the number of human subjects that
are to be involved in such testing;
``(iii) the need to permit changes to be
made in the in vitro clinical test involved
during testing conducted in accordance with a
plan required under paragraph (3)(B); or
``(iv) whether the clinical testing of such
in vitro clinical test is for the purpose of
developing data to obtain approval to offer
such test.
``(C) Significant risk studies.--In the case of an
in vitro clinical test the investigational use of which
poses a significant risk, a sponsor of an investigation
of such a test seeking an investigational use exemption
shall submit to the Secretary an investigational use
application with respect to the test in accordance with
paragraphs (2) and (3). For purposes of this
subparagraph, the term `significant risk' means, with
respect to an in vitro clinical test that is a high-
risk test, and that the use of the test--
``(i) is a use of substantial importance in
performing an activity or activities described
in subsection (ss)(1)(A) for, a serious or
life-threatening disease or condition without
confirmation of the diagnosis by a medically
established means;
``(ii) requires an invasive sampling
procedure that presents a significant risk to
the human subject; or
``(iii) otherwise presents a reasonably
foreseeable serious risk to the health of a
human subject.
``(D) Non-significant risk tests.--In the case of
an in vitro clinical test, the investigational use of
which does not pose a significant risk--
``(i) the sponsor of such investigation
shall--
``(I) conduct such investigation in
compliance with an investigational plan
specified in paragraph (5) and labeling
specified in paragraph (3)(A)(ii);
``(II) ensure each investigator
obtains informed consent under part 50
of title 21, Code of Federal
Regulations (or any successor
regulations), subject to the exceptions
set forth in paragraphs (5)(A)(iii) and
(5)(B);
``(III) submit a listing to the
Secretary of such investigation; and
``(IV) maintain records with
respect to all requirements in this
subparagraph; and
``(ii) the sponsor may rely on any
exception or exemption identified in paragraph
(5)(B) or as established by the Secretary in
regulations issued under subsection (b).
``(2) Application content.--An investigational use
application shall be submitted in such time and manner and
contain such information as the Secretary may require in
regulation, and shall include an investigational plan for
proposed clinical testing and assurances that the sponsor
submitting the application will--
``(A) establish and maintain records relevant to
the investigation of such in vitro clinical test; and
``(B) submit to the Secretary annual reports of
data obtained as a result of the investigational use of
the in vitro clinical test during the period covered by
the exemption that the Secretary reasonably determines
will enable the Secretary--
``(i) to ensure compliance with the
conditions for the exemption specified in
paragraph (3);
``(ii) to review the progress of the
investigation involved; and
``(iii) to evaluate the analytical validity
and clinical validity of such test.
``(3) Conditions for exemption.--
``(A) In general.--A request for an investigational
use exemption with respect to significant risk tests
shall be granted only if each of the following
conditions is met:
``(i) The risks to the subjects of the in
vitro clinical test are outweighed by the
anticipated benefits to the subjects and the
importance of the knowledge to be gained, and
adequate assurance of informed consent is
provided in accordance with paragraph
(5)(A)(iii).
``(ii) The proposed labeling for the in
vitro clinical test involved clearly and
conspicuously states `For investigational use'.
``(iii) Such other requirements the
Secretary determines to be necessary for the
protection of the public health and safety as
long as the requirements do not unduly delay
investigation after finding that the results of
such investigation establish sufficient data to
support clinical or analytical validity.
``(B) Certain significant risk in vitro clinical
tests for an unmet need.--As a condition for granting
an exemption under this paragraph, the Secretary shall
not impose a limit on the sample size for a significant
risk in vitro clinical test that meets the requirements
of section 587C, as long as such test is developed
within a laboratory that is certified to conduct high-
complexity testing under section 353 of the Public
Health Service Act.
``(4) Coordination with investigational new drug
applications.--Any requirement for the submission of a report
to the Secretary pursuant to a request for an investigational
new drug exemption involving an in vitro clinical test shall
supersede the reporting requirement in paragraph (2)(B), but
only to the extent the requirement with respect to the request
for exemption with respect to the drug is duplicative of the
reporting requirement under such paragraph.
``(5) Investigation plan requirements.--
``(A) In general.--With respect to an
investigational plan submitted under paragraph (2)(A),
the sponsor submitting such plan shall--
``(i) in the case of such a plan submitted
to an institutional review committee, promptly
notify the Secretary of the approval or the
suspension or termination of the approval of
such plan by an institutional review committee;
``(ii) in the case of an in vitro clinical
test made available to investigators for
clinical testing, assurance that all
investigators will comply with this section,
regulations promulgated or revised under this
section, and applicable human subjects
regulations; and
``(iii) submit an assurance to the
Secretary that informed consent will be
obtained from each human subject (or the
representative of such subject) of proposed
clinical testing involving such in vitro
clinical test, except in the case that--
``(I) there is a life-threatening
situation involving the human subject
of such testing which necessitates the
use of such in vitro clinical test;
``(II) it is not feasible to obtain
informed consent from the subject; and
``(III) there is not sufficient
time to obtain such consent from a
representative of such subject.
``(B) Exception.--The informed consent of human
subjects shall not be required with respect to clinical
testing conducted as part of an investigation, if--
``(i) the clinical testing uses remnants of
specimens collected for routine clinical care
or analysis that would have been discarded,
leftover specimens that were previously
collected for other research purposes, or
specimens obtained from specimen repositories;
``(ii) the identity of the subject of the
specimen is not known to, and may not readily
be ascertained by, the investigator or any
other individual associated with the
investigation, including the sponsor;
``(iii) any clinical information that
accompanies the specimens does not make the
specimen source identifiable to the
investigator or any other individual associated
with the investigation, including the sponsor;
``(iv) the individuals caring for the human
subjects as patients are different from, and do
not share information about the patient with,
the individuals conducting the investigation;
and
``(v) the specimens are provided to the
investigators without personally identifiable
information and the supplier of the specimens
has established policies and procedures to
prevent the release of personally identifiable
information.
``(d) Review of Applications.--
``(1) In general.--The Secretary may issue an order
approving an investigation as proposed, approving it with
conditions or modifications, or disapproving it.
``(2) Failure to act.--Unless the Secretary, not later than
the date that is 30 calendar days after the date of the
submission of an investigational use exemption request that
meets the requirements of subsection (c)(2), issues an order
under subsection (d)(1) and notifies the sponsor submitting the
application, the request shall be treated as granted as of such
date without further action by the Secretary.
``(3) Disapproval.--The Secretary may deny an
investigational use request submitted under this subsection if
the Secretary determines that the investigation with respect to
which the request is submitted does not conform to the
requirements of subsection (c)(3). A listing of such denial
submitted to the sponsor with respect to such a request shall
contain the order of disapproval and a complete statement of
the reasons for the Secretary's denial of the request.
``(e) Withdrawal of Approval.--
``(1) In general.--The Secretary may, by administrative
order, withdraw an exemption granted under this section with
respect to an in vitro clinical test, including an exemption
granted based on the Secretary's failure to act pursuant to
subsection (d)(2), if the Secretary determines that the test
does not meet the applicable conditions under subsection (c)(3)
for such exemption.
``(2) Opportunity to be heard.--
``(A) In general.--Subject to subparagraph (B), an
order withdrawing the exemption granted under this
section may be issued only after the Secretary provides
the applicant or sponsor of the test with an
opportunity for an informal hearing.
``(B) Exception.--An order referred to in
subparagraph (A) with respect to an exemption granted
under this subsection may be issued on a preliminary
basis before the provision of an opportunity for an
informal hearing if the Secretary determines that the
continuation of testing under the exemption will result
in an unreasonable risk to the public health. The
Secretary will provide an opportunity for an informal
hearing promptly following any preliminary action under
this subparagraph.
``(f) Changes.--
``(1) In general.--The regulations promulgated under
subsection (b) shall provide, with respect to an in vitro
clinical test for which an exemption under this subsection is
in effect, procedures and conditions under which the changes to
the test are allowed without the additional determination on a
request for an exemption or submission of a supplement to such
a request. Such regulations shall provide that such a change
may be made if--
``(A) the sponsor or applicant determines, on the
basis of credible information (as defined by the
Secretary) that the change meets the conditions
specified in paragraph (2); and
``(B) the sponsor or applicant submits to the
Secretary, not later than 5 calendar days after making
the change, a notice of the change.
``(2) Conditions.--The conditions specified in this
paragraph are that--
``(A) in the case of developmental changes to an in
vitro clinical test (including manufacturing changes),
the changes--
``(i) do not constitute a significant
change in design or in basic principles of
operation;
``(ii) do not affect the rights, safety, or
welfare of the human subjects (if any) involved
in the investigation; and
``(iii) are made in response to information
gathered during the course of an investigation;
and
``(B) in the case of changes to clinical protocols
applicable to the test, the changes do not affect--
``(i) the validity of data or information
resulting from the completion of an approved
clinical protocol;
``(ii) the scientific soundness of a plan
submitted under subsection (c)(5); or
``(iii) the rights, safety, or welfare of
the human subjects (if any) involved in the
investigation.
``(g) Clinical Hold.--
``(1) In general.--At any time, the Secretary may impose a
clinical hold with respect to an investigation of an in vitro
clinical test if the Secretary makes a determination described
in paragraph (2). The Secretary shall, in imposing such
clinical hold, specify the basis for the clinical hold,
including the specific information available to the Secretary
which served as the basis for such clinical hold, and confirm
such determination in writing. The applicant or sponsor may
immediately appeal any such determination pursuant to section
587O.
``(2) Determination.--For purposes of paragraph (1), a
determination described in this subparagraph with respect to a
clinical hold is a determination that--
``(A) the in vitro clinical test involved
represents an unreasonable risk to the safety of the
persons who are the subjects of the clinical
investigation, taking into account the qualifications
of the clinical investigators, information about the in
vitro clinical test, the design of the clinical
investigation, the condition for which the in vitro
clinical test is to be investigated, and the health
status of the subjects involved;
``(B) the clinical hold should be issued for such
other reasons as the Secretary may by regulation
establish; or
``(C) any written request to the Secretary from the
sponsor of an investigation that a clinical hold be
removed shall receive a decision, in writing and
specifying the reasons therefor, within 30 days after
receipt of such request. Any such request shall include
sufficient information to support the removal of such
clinical hold.
``SEC. 587S. COLLABORATIVE COMMUNITIES FOR IN VITRO CLINICAL TESTS.
``(a) In General.--
``(1) For the purposes of facilitating community solutions
and decision making with respect to in vitro clinical tests,
the Secretary may participate in collaborative communities
comprised of public and private participants that may provide
recommendations and other advice to the Secretary on the
development and regulation of in vitro clinical tests.
``(2) A collaborative community under this section shall
have broad representation of interested private and public-
sector stakeholder communities and may include patients, care
partners, academics, health care professionals, health care
systems, payors, Federal and State agencies, entities
responsible for accrediting clinical laboratories,
international regulatory bodies, test developers, or other
interested entities or communities.
``(b) Guidance.--The Secretary shall issue a draft guidance not
later than 180 days after the date of enactment of the Verifying
Accurate Leading-edge IVCT Development Act of 2021, addressing the
participation process and framework to build consensus, and how the
Secretary may consider, review, and implement recommendations under
subsection (c).
``(c) Recommendations.--A collaborative community for in vitro
clinical tests may make recommendations to the Secretary on matters
including--
``(1) mitigating measures for in vitro clinical tests;
``(2) standards development activities and performance
standards for in vitro clinical tests or groups of such tests;
``(3) scientific and clinical evidence to support new
claims for in vitro clinical tests;
``(4) new technologies and methodologies related to in
vitro clinical tests;
``(5) stakeholder communication and engagement; and
``(6) development of effective policies and processes,
including to develop tests, and to regulate such tests in
accordance with least burdensome requirements described in
section 587B(j).
``(d) Use by Secretary.--
``(1) In general.--The Secretary may adopt recommendations
made under subsection (b), or otherwise incorporate the
feedback from collaborative communities into regulatory
decision making, through rulemaking or guidance, as
appropriate.
``(2) Clarification.--The Secretary is not required to
adopt recommendations submitted by collaborative communities.
``(e) Transparency.--The Secretary shall--
``(1) publish on the website of the Food and Drug
Administration matters for which it is seeking comments or
recommendations, in a timely manner;
``(2) maintain a list of all collaborative communities in
which the Secretary participates and make such list available
on the website of the Food and Drug Administration; and
``(3) post on the website of the Food and Drug
Administration at least once every year a report on the
recommendations it has adopted and recommendations it has not
adopted from collaborative communities.
``(f) Participation.--The Secretary may participate in a
collaborative community only if such community requires members to
disclose conflicts of interest and has established a process to address
conflicts of interest.
``(g) Exemption.--The collaborative communities established and
used in accordance with this section shall be exempt from the Federal
Advisory Committee Act (5 U.S.C. App.).
``SEC. 587T. COMPREHENSIVE TEST INFORMATION SYSTEM.
``(a) Purpose.--For the purposes of improving the transparency of
information on in vitro clinical tests and allowing patients and health
care providers better access to information about in vitro clinical
tests, the Secretary shall establish a comprehensive test information
system.
``(b) Establishment.--Not later than 2 years after the date of
enactment of the Verifying Accurate Leading-edge IVCT Development Act
of 2021, the Secretary shall make available a comprehensive test
information system for in vitro clinical tests that is designed to--
``(1) provide a transparent interface on the website of the
Food and Drug Administration for stakeholders, to the extent
permitted by applicable law, to access the--
``(A) regulatory pathway designation information
for each in vitro clinical test or tests with the same
indications for use;
``(B) registration and listing information provided
by developers under section 587I, including the use of
a link for labels;
``(C) adverse event reports submitted under section
587L;
``(D) reports of corrections and removals submitted
under section 587M; and
``(E) other information pertaining to an in vitro
clinical test or tests with the same indications for
use, as the Secretary determines appropriate; and
``(2) provide a secure portal for electronic submission,
including applications and other in vitro clinical test
submissions, registration and listing information, and adverse
event reports.
``(c) Submission Function.--The comprehensive test information
system shall serve as the electronic submission service for test
developers submitting information for applications under sections 587B
and 587D.
``SEC. 587U. PREEMPTION.
``(a) In General.--No State, Tribal, or local government (or
political subdivision thereof) may establish or continue in effect any
requirement related to the development, manufacture, labeling,
distribution, sale, or use of an in vitro clinical test that is
different from, or in addition to, the requirements of this subchapter.
``(b) Exceptions.--Subsection (a) shall not be construed to affect
the authority of a State, Tribal, or local government--
``(1) to license laboratory personnel, health care
practitioners, or health care facilities or to regulate any
aspect of a health care practitioner-patient relationship; or
``(2) to enforce laws of general applicability, such as
zoning laws, environmental laws, labor laws, and general
business laws.
``(c) Clarification.--This section shall not be construed to shift
liability to health care practitioners or other users.
``SEC. 587V. ADULTERATION.
``An in vitro clinical test shall be deemed to be adulterated:
``(1) If it consists in whole or in part of any filthy,
putrid, or decomposed substance.
``(2) If it has been developed, prepared, packed, or held
under insanitary conditions whereby it may have been
contaminated with filth, or whereby it may have been rendered
injurious to health.
``(3) If its container or package is composed, in whole or
in part, of any poisonous or deleterious substance which may
render the contents injurious to health.
``(4) If it bears or contains, for purposes of coloring
only, a color additive which is unsafe within the meaning of
section 721(a).
``(5) If its analytical or clinical validity, or with
respect to a specimen receptacle, its safety, or its strength,
purity, or quality, differs from or falls below that which it
purports or is represented to possess.
``(6) If it is required to be, declared to be, purports to
be, or is represented as being, in conformity with any
performance standard established or recognized under section
587Q and is not in all respects in conformity with such
standard.
``(7) If it is required to be in conformity with a
mitigating measure established under section 587E and is not in
all respects in conformity with such mitigating measure.
``(8) If it fails to have an approved premarket application
under section 587B unless such in vitro clinical test can be
lawfully offered--
``(A) for clinical use pursuant to an exemption
under section 587A;
``(B) for emergency use pursuant to an
authorization under section 564; or
``(C) for investigational use pursuant to section
587R.
``(9) If it is not in conformity with any condition
established under section 587B, 587D, or 564.
``(10) If it purports to be an in vitro clinical test that
is offered for clinical use subject to an exemption under
section 587A and it fails to meet or maintain any criteria,
condition, or requirement of such exemption.
``(11) If it has been granted an exemption under section
587R for investigational use, and the person granted such
exemption or any investigator who uses such in vitro clinical
test under such exemption fails to comply with a requirement
prescribed by or under such section.
``(12) If it fails to meet the quality requirements
prescribed in or established under section 587J (as
applicable), or the methods used in, or facilities or controls
used for, its development, manufacture, packing, storage, or
installation are not in conformity with applicable requirements
established under such section.
``(13) If it has been developed, manufactured, processed,
packed or held in any establishment, factory, or warehouse and
the owner, operator or agent of such establishment, factory, or
warehouse delays, denies, or limits an inspection, or refuses
to permit entry or inspection.
``(14) If it is not in compliance with any restriction
required under section 587N.
``SEC. 587W. MISBRANDING.
``An in vitro clinical test shall be deemed to be misbranded:
``(1) If its labeling is false or misleading in any
particular.
``(2) If in a package form unless it bears a label
containing--
``(A) the name and place of business of the test
developer, manufacturer, packer, or distributor; and
``(B) an accurate statement of the quantity of
contents in terms of weight, measure, or numerical
count with respect to small packages, unless an
exemption is granted by the Secretary by the issuance
of guidance.
``(3) If any word, statement, or other information required
by or under authority of this Act to appear on the label or
labeling, including a test report, is not prominently placed
thereon with such conspicuousness (as compared with other
words, statements, designs, or devices, in the labeling) and in
such terms as to render it likely to be read and understood by
the ordinary individual under customary conditions of purchase
and use.
``(4) Unless its labeling bears adequate directions for use
and such adequate warnings as are necessary for the protection
of users of the in vitro clinical test and recipients of the
results of such in vitro clinical test, including patients,
consumers, donors, and related health care professionals.
Required labeling for in vitro clinical tests intended for use
in health care facilities or by a health care professional may
be made available solely by electronic means, provided that the
labeling complies with all applicable requirements of law, and
that the test developer, manufacturer, or distributor affords
such users the opportunity to request the labeling in paper
form, and after such request, promptly provides the requested
information without additional cost.
``(5) If it causes serious or adverse health consequences
or death, including through absence, delay, or discontinuation
in diagnosis or treatment, when used in the manner prescribed,
recommended, or suggested in the labeling thereof.
``(6) If it was developed or manufactured in an
establishment not duly registered under section 587I or it was
not included in a listing under section 587I, in accordance
with timely reporting requirements under this subchapter.
``(7) In the case of any in vitro clinical test subject to
restrictions under section 587N, (1) if its advertising is
false or misleading in any particular, (2) if it is offered for
clinical use, sold, distributed, or used in violation of such
restrictions, or (3) unless the test developer, manufacturer,
or distributor includes in all advertisements and other
descriptive printed matter that such person issues or causes to
be issued, a brief statement of the intended uses of the in
vitro clinical test and relevant warnings, precautions, side
effects, and contraindications. This subsection shall not be
applicable to any printed matter that the Secretary determines
to be labeling as defined in section 201(m) or section 587K.
``(8) If it was subject to a mitigating measure established
under section 587E, unless it bears such labeling as may be
prescribed in such mitigating measure.
``(9) If it was subject to a standard established under
section 587Q, unless it bears such labeling as may be
prescribed in such standard.
``(10) Unless it bears such labeling as may be prescribed
by or established under an applicable labeling requirement
under this Act.
``(11) If there was a failure or refusal to comply with any
requirement prescribed under section 587I or 587X, or to comply
with a requirement under section 587Y, or to provide any
report, material, or information required under this
subchapter.
``SEC. 587X. POSTMARKET SURVEILLANCE.
``(a) In General.--
``(1) In general.--In addition to other applicable
requirements under this Act, the Secretary may issue an order
requiring a developer to conduct postmarket surveillance of a
single in vitro clinical test as a condition of approval under
section 587B.
``(2) Exempt tests.--The Secretary may order postmarket
surveillance for tests exempt pursuant to section 587A for
which the failure of the in vitro clinical test to meet the
applicable standard for approval is likely to result in serious
or adverse health consequences or death from use of the single
in vitro clinical test.
``(3) Consideration.--In determining whether to require a
developer to conduct postmarket surveillance of an in vitro
clinical test, the Secretary shall take into consideration the
benefits and risks for the patient and the least burdensome
principles under section 587B.
``(b) Surveillance Approval.--
``(1) Each developer required to conduct a surveillance of
an in vitro clinical test shall submit, within 30 days of
receiving an order from the Secretary, a plan for the required
surveillance. The Secretary, within 60 days of the receipt of
such plan, shall determine if the person designated to conduct
the surveillance has the appropriate qualifications and
experience to undertake such surveillance and if the plan will
result in useful data that can reveal unforeseen adverse events
or other information necessary to protect the health of
patients or the public.
``(2) The developer shall commence surveillance under this
section not later than 15 months after the day on which the
Secretary orders such postmarket surveillance, unless the
Secretary determines more time is needed to commence
surveillance.
``(3) The Secretary may order a prospective surveillance
period of up to 3 years. Any determination by the Secretary
that a longer period is necessary shall be made by mutual
agreement between the Secretary and the manufacturer or, if no
agreement can be reached, after the completion of a dispute
resolution process.
``SEC. 587Y. ELECTRONIC FORMAT FOR SUBMISSIONS.
``(a) In General.--All presubmissions and submissions to the Food
and Drug Administration with respect to an in vitro clinical test shall
include an electronic copy of such presubmission or submission, and,
with respect to the information required under sections 587B and 587D,
shall utilize the system described in section 587T.
``(b) Electronic Format.--Beginning on such date as the Secretary
specifies in final guidance issued under subsection (c), presubmissions
and submissions for in vitro clinical tests (and any appeals of action
taken by the Secretary with respect to such presubmissions and
submissions) shall be submitted solely in such electronic format as
specified by the Secretary in such guidance.
``(c) Guidance.--The Secretary shall issue guidance implementing
this section. In such guidance, the Secretary may--
``(1) provide standards for the electronic copy required
under subsection (a) or the submission in electronic format
required under subsection (b);
``(2) set forth criteria for waivers of or exemptions from
the requirements of subsection (a) or (b); and
``(3) provide any other information for the efficient
implementation and enforcement of this section.
``SEC. 587Z. POSTMARKET REMEDIES.
``(a) Safety Notice.--
``(1) In general.--If the Secretary determines that an in
vitro clinical test presents an unreasonable risk of
substantial harm to the public health, and notification under
this subsection is necessary to eliminate the unreasonable risk
of such harm and no more practicable means is available under
the provisions of this Act (other than this section) to
eliminate the risk, the Secretary may issue such order as may
be necessary to ensure that adequate safety notice is provided
in an appropriate form, by the persons and means best suited
under the circumstances, to all health care professionals who
prescribe, order, or use the in vitro clinical test and to any
other person (including developers, manufacturers, importers,
distributors, retailers, and users) who should properly receive
such notice.
``(2) Notice to individuals.--An order under this
subsection shall require that the individuals subject to the
risk with respect to which the order is to be issued be
included in the persons to be notified of the risk unless the
Secretary determines that notice to such individuals would
present a greater danger to the health of such individuals than
no such notice. If the Secretary makes such a determination
with respect to such individuals, the order shall advise the
health care professionals who prescribed, ordered, or used the
in vitro clinical test provide notification to the individuals
for whom the health professionals prescribed, ordered, or used
such test, of the risk presented by such in vitro clinical test
and of any action which may be taken by or on behalf of such
individuals to eliminate or reduce such risk. Before issuing an
order under this subsection, the Secretary shall consult with
the persons required to give notice under the order.
``(b) Repair, Replacement, or Refund.--
``(1) Determination after an informal hearing.--
``(A) In general.--If, after affording opportunity
for an informal hearing, the Secretary determines
that--
``(i) an in vitro clinical test presents an
unreasonable risk of substantial harm to the
public health;
``(ii) there are reasonable grounds to
believe that the in vitro clinical test was not
properly developed or manufactured considering
the state of the art as it existed at the time
of its development or manufacture;
``(iii) there are reasonable grounds to
believe that the unreasonable risk was not
caused by failure of a person other than a
developer, manufacturer, importer, distributor,
or retailer of the in vitro clinical test to
exercise due care in the installation,
maintenance, repair, or use of the in vitro
clinical test; and
``(iv) the notice authorized by subsection
(a) would not by itself be sufficient to
eliminate the unreasonable risk and action
described in paragraph (2) of this subsection
is necessary to eliminate such risk,
the Secretary may order the developer, manufacturer,
importer, or any distributor of such in vitro clinical
test, or any combination of such persons, to submit to
him within a reasonable time a plan for taking one or
more of the actions described in paragraph (2). An
order issued under the preceding sentence which is
directed to more than one person shall specify which
person may decide which action shall be taken under
such plan and the person specified shall be the person
who the Secretary determines bears the principal,
ultimate financial responsibility for action taken
under the plan unless the Secretary cannot determine
who bears such responsibility or the Secretary
determines that the protection of the public health
requires that such decision be made by a person
(including a health professional or user of the in
vitro clinical test) other than the person the
Secretary determines bears such responsibility.
``(B) Secretary approval of plan.--Within 30
calendar days of issuing an order under subparagraph
(A), the Secretary shall approve a plan submitted
pursuant to an order issued under subparagraph (A)
unless the Secretary determines (after affording
opportunity for an informal hearing) that the action or
actions to be taken under the plan or the manner in
which such action or actions are to be taken under the
plan will not assure that the unreasonable risk with
respect to which such order was issued will be
eliminated. If the Secretary disapproves a plan, the
Secretary shall order a revised plan to be submitted
within a reasonable time. If the Secretary determines
(after affording opportunity for an informal hearing)
that the revised plan is unsatisfactory or if no
revised plan or no initial plan has been submitted to
the Secretary within the prescribed time, the Secretary
shall (i) prescribe a plan to be carried out by the
person or persons to whom the order issued under
subparagraph (A) was directed, or (ii) after affording
an opportunity for an informal hearing, by order
prescribe a plan to be carried out by a person who is a
manufacturer, importer, distributor, or retailer of the
in vitro clinical test with respect to which the order
was issued but to whom the order under subparagraph (A)
was not directed.
``(2) Actions on a plan.--The actions which may be taken
under a plan submitted under an order issued under paragraph
(1) are as follows:
``(A) To repair the in vitro clinical test so that
it does not present the unreasonable risk of
substantial harm with respect to which the order under
paragraph (1)(A) was issued.
``(B) To replace the in vitro clinical test with a
like or equivalent test which is in conformity with all
applicable requirements of this Act.
``(C) To refund the purchase price of the in vitro
clinical test (less a reasonable allowance for use if
such in vitro clinical test has been in the possession
of the user for one year or more at the time of notice
ordered under subsection (a), or at the time the user
receives actual notice of the unreasonable risk with
respect to which the order was issued under paragraph
(1)(A), whichever occurs first).
``(3) No charge.--No charge shall be made to any person
(other than a developer, manufacturer, importer, distributor or
retailer) for using a remedy described in paragraph (2) and
provided under an order issued under paragraph (1), and the
person subject to the order shall reimburse each person (other
than a developer, manufacturer, importer, distributor, or
retailer) who is entitled to such a remedy for any reasonable
and foreseeable expenses actually incurred by such person in
availing himself of such remedy.
``(c) Reimbursement.--An order issued under subsection (b)(1)(A)
with respect to an in vitro clinical test may require any person who is
a developer, manufacturer, importer, distributor, or retailer of the in
vitro clinical test to reimburse any other person who is a developer,
manufacturer, importer, distributor, or retailer of such in vitro
clinical test for such other person's expenses actually incurred in
connection with carrying out the order if the Secretary determines such
reimbursement is required for the protection of the public health. Any
such requirement shall not affect any rights or obligations under any
contract to which the person receiving reimbursement or the person
making such reimbursement is a party.
``(d) Recall Authority.--
``(1) In general.--If the Secretary finds that there is a
reasonable probability that an in vitro clinical test approved
under section 587B would cause serious, adverse health
consequences or death, including by the absence, delay, or
discontinuation of appropriate medical treatment, the Secretary
shall issue an order requiring the appropriate person
(including the developers, manufacturers, importers,
distributors, or retailers of the in vitro clinical test)--
``(A) to immediately cease distribution of such in
vitro clinical test; and
``(B) to immediately notify health professionals
and user facilities of the order and to instruct such
professionals and facilities to cease use of such in
vitro clinical test.
``(2) Informal hearing.--The order issued under paragraph
(1)(A), shall provide the person subject to the order with an
opportunity for an informal hearing, to be held not later than
10 calendar days after the date of the issuance of the order,
on the actions required by the order and on whether the order
should be amended to require a recall of such in vitro clinical
test. If, after providing an opportunity for such a hearing,
the Secretary determines that inadequate grounds exist to
support the actions required by the order, the Secretary shall
vacate the order.
``(3) Amended order.--
``(A) In general.--If, after providing an
opportunity for an informal hearing under paragraph
(2), the Secretary determines that the order should be
amended to include a recall of the in vitro clinical
test with respect to which the order was issued, the
Secretary shall, except as provided in subparagraph
(B), amend the order to require a recall. The Secretary
shall specify a timetable in which the recall will
occur and shall require periodic reports describing the
progress of the recall.
``(B) Requirements.--An amended order under
subparagraph (A)--
``(i) shall not include recall of the in
vitro clinical test from individuals;
``(ii) shall not include recall of an in
vitro clinical test from test user facilities
if the Secretary determines that the risk of
recalling such in vitro clinical test from the
facilities presents a greater health risk than
the health risk of not recalling the in vitro
clinical test from use; and
``(iii) shall provide for notice to
individuals subject to the risks associated
with the use of such in vitro clinical test. In
providing the notice required by this clause,
the Secretary may use the assistance of health
professionals who prescribed, ordered, or used
such an in vitro clinical test for individuals.
``(4) Clarification.--The remedy provided by this
subsection shall be in addition to remedies provided by
subsections (b) and (c).''.
SEC. 4. ENFORCEMENT AND OTHER PROVISIONS.
(a) Prohibited Acts.--Section 301 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331) is amended--
(1) in paragraphs (a), (b), (c), (g), (k), (q), (r), and
(y), by inserting ``in vitro clinical test,'' after ``device,''
each place it appears;
(2) in paragraph (y) by inserting ``or 587P'' after
``section 523'' each place it appears; and
(3) by adding at the end, the following:
``(fff)(1) The introduction or delivery for introduction into
interstate commerce of an in vitro clinical test in violation of
section 587B(a).
``(2) The false, fraudulent, or deceptive claiming for an in vitro
clinical test of an exemption from the premarket review required under
section 587B.
``(3) When claiming an exemption under section 587A from the
premarket review required under section 587B, the failure to maintain
complete and accurate documentation for the exemption as required under
section 587A or the failure to provide labeling required under section
587A.
``(4) With respect to an in vitro clinical test, the submission of
any report that is required by or under this Act that is false or
misleading in any material respect.
``(5) The making of a false, fraudulent, or materially deceptive
analytical or clinical claim for an in vitro clinical test--
``(A) in any application, report, or notification submitted
to the Secretary under this Act; or
``(B) in the labeling or advertising of an in vitro
clinical test.
``(6) The failure to comply with a condition of approval,
performance standard, mitigating measure, or restriction established in
an order approving an application or supplement under section 587B; the
failure to perform a risk analysis required by section 587B; the
failure to submit an annual report required under section 587B(k); or
the failure to complete postmarket studies required under section 587V.
``(7) The marketing of an in vitro clinical test in violation of--
``(A) an order issued by the Secretary under section 587A;
or
``(B) any requirement under section 587A.
``(8) With respect to technology certification under section 587D,
the refusal to permit, or unreasonable delay in permitting, an
inspection authorized under section 587D(f)(3)(G); the failure to
comply with applicable requirements to submit an application or report
under section 587D(e); or the failure to comply with applicable
maintenance requirements under section 587D(h).
``(9) The failure to comply with an applicable mitigating measure
established under section 587E or to maintain the documentation
required under section 587E(b); or the failure to comply with a
performance standard established under section 587Q.
``(10) The failure to register in accordance with section 587I, the
failure to provide information required under section 587I(b), or the
failure to maintain or submit information required under section
587I(c).
``(11) The failure to submit a report required under section 587L
or 587M; the failure to comply with a restriction imposed under section
587N; or the failure to comply with labeling and advertising
requirements under section 587N(b).
``(12) The failure to comply with the requirements of section 587P
(relating to accredited persons).
``(13) The failure to comply with any requirement prescribed or
established under section 587R; the failure to furnish any
notification, information, material, or report required under section
587R; or the failure to comply with an order issued under section
587R.''.
(b) Penalties.--Section 303(f)(1) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 333(f)(1)) is amended--
(1) in subparagraph (A), by inserting ``or in vitro
clinical tests'' after ``devices''; and
(2) in subparagraph (B)(i)--
(A) by inserting ``, or 587J or 587L,'' after
``520(f)''; and
(B) by inserting ``, or who violates section
587M(b) with respect to a correction report'' after
``risk to public health''.
(c) Seizure.--Section 304 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 334) is amended--
(1) in subsection (a)(2)--
(A) by striking ``and'' before ``(E) Any''; and
(B) by inserting ``, and (F) Any adulterated or
misbranded in vitro clinical test'' after ``tobacco
product'';
(2) in subsection (d)(1), by inserting ``in vitro clinical
test,'' after ``device,''; and
(3) in subsection (g)--
(A) in paragraph (1), by inserting ``, in vitro
clinical test,'' after ``device'' each place it
appears; and
(B) in paragraph (2)--
(i) in subparagraph (A), by inserting ``,
in vitro clinical test,'' after ``device''; and
(ii) in subparagraph (B), by inserting ``or
in vitro clinical test'' after ``device'' each
place it appears.
(d) Debarment, Temporary Denial of Approval, and Suspension.--
Section 306 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
335a) is amended by adding at the end the following:
``(n) In Vitro Clinical Tests; Mandatory Debarment Regarding Third-
Party Inspections and Reviews.--
``(1) In general.--If the Secretary finds that a person has
been convicted of a felony under section 301(gg), 301(fff)(2),
301(fff)(5), or 301(fff)(8), the Secretary shall debar such
person from being accredited under section 587P and from
carrying out activities under an agreement described in section
803(b).
``(2) Debarment period.--The Secretary shall debar a person
under paragraph (1) for the following periods:
``(A) The period of debarment of a person (other
than an individual) shall not be less than 1 year or
more than 10 years, but if an act leading to a
subsequent debarment under such paragraph occurs within
10 years after such person has been debarred under such
paragraph, the period of debarment shall be permanent.
``(B) The debarment of an individual shall be
permanent.
``(3) Termination of debarment; judicial review; other
matters.--Subsections (c)(3), (d), (e), (i), (j), and (l)(1)
apply with respect to a person (other than an individual) or an
individual who is debarred under paragraph (1) to the same
extent and in the same manner as such subsections apply with
respect to a person who is debarred under subsection (a)(1), or
an individual who is debarred under subsection (a)(2),
respectively.''.
(e) Judicial Review.--Section 517(a) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360g(a)) is amended--
(1) in paragraph (8), by striking ``or'' at the end;
(2) in paragraph (9), by inserting ``or'' after the comma
at the end; and
(3) before the matter that follows paragraph (9), by
inserting the following:
``(10) an order issued pursuant to section 587B, 587D,
587R, or 587S,''.
(f) Expanded Access to Unapproved Therapies and Diagnostics.--
Section 561 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360bbb) is amended--
(1) in subsections (a) through (d)--
(A) by striking ``or investigational devices'' each
place it appears and inserting ``, investigational
devices, or investigational in vitro clinical tests'';
and
(B) by striking ``or investigational device'' each
place it appears (other than the second such place in
paragraph (3)(A)) and inserting ``, investigational
device, or investigational in vitro clinical test'';
(2) in subsection (b)(4) by striking ``or 520(g)'' and
inserting ``, 520(g), or 587R'' each place it appears;
(3) in subsection (c)--
(A) by amending the subsection heading to read:
``Treatment Investigational New Drug Applications,
Treatment Investigational Device Exemptions, and
Treatment Investigational in Vitro Clinical Test
Exemptions'';
(B) in paragraph (3)(A), by striking ``or
investigational device exemption in effect under
section 520(g)'' and inserting ``, investigational
device exemption in effect under section 520(g), or
investigational in vitro clinical test exemption under
section 587R'';
(C) by striking ``or treatment investigational
device exemption'' each place it appears and inserting
``, treatment investigational device exemption, or
treatment investigational in vitro clinical test
exemption''; and
(D) in the matter following paragraph (7) by
striking ``or 520(g)'' each place it appears and
inserting ``, 520(g) or 587R''; and
(4) by amending subsection (e) to read as follows:
``(e) Definitions.--In this section, the terms `investigational
drug', `investigational device', `investigational in vitro clinical
test', `treatment investigational new drug application', `treatment
investigational device exemption', and `treatment investigational in
vitro clinical test exemption' shall have the meanings given the terms
in regulations prescribed by the Secretary.''.
(g) Optimizing Global Clinical Trials.--Section 569A(b) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-8a(b)) is
amended by inserting ``an in vitro clinical test, as defined in
subsection (ss) of such section,'' before ``or a biological product''.
(h) Patient Participation in Medical Product Discussion.--The
heading of subsection (a) of section 569C of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360bbb-8c) is amended by striking ``Drugs
and Devices'' and inserting ``Drugs, Devices, and In Vitro Clinical
Tests''.
(i) Regulations and Hearings.--Section 701(h)(1)(C)(ii) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371(h)(1)(C)(ii)) is
amended by inserting ``and in vitro clinical tests'' after ``devices''.
(j) Factory Inspection.--Section 704 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 374) (other than subsection (g)) is amended--
(1) by striking ``drugs or devices'' each place it appears
and inserting ``drugs, devices, or in vitro clinical tests'';
(2) in subsection (a)(1), in the third sentence, by
striking ``or chapter IX'' and inserting ``section 587R or
chapter IX'';
(3) in subsection (a)(2)(B)--
(A) by inserting ``or in vitro clinical tests''
after ``prescribe or use devices''; and
(B) by inserting ``or in vitro clinical tests''
after ``process devices'';
(4) by inserting ``in vitro clinical test,'' after
``device,'' each place it appears;
(5) after making the amendments in paragraphs (1) and (2),
by inserting ``in vitro clinical tests,'' after ``devices,''
each place it appears;
(6) in subsection (e), by inserting ``, or section 587L,
587M, or 587R,'' after ``section 519 or 520(g)''; and
(7) in subsection (f)(3)--
(A) in subparagraph (A), by striking ``or'' at the
end;
(B) in subparagraph (B), by striking the period at
the end and inserting ``; or''; and
(C) after subparagraph (B), by inserting the
following:
``(C) is accredited under section 587P.''.
(k) Publicity.--Section 705(b) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 375(b)) is amended by inserting ``in vitro
clinical tests,'' after ``devices,''.
(l) Presumption.--Section 709 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379a) is amended by inserting ``in vitro
clinical test,'' after ``device,''.
(m) Imports and Exports.--Section 801 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 381) is amended--
(1) in subsection (a)--
(A) by inserting ``in vitro clinical tests,'' after
``devices,'' each place it appears; and
(B) by inserting ``in the case of an in vitro
clinical test, the test does not conform to the
applicable requirements of section 587J, or'' after
``requirements of section 520(f), or'';
(2) in subsection (d)(3)--
(A) in subparagraph (A)--
(i) in the matter preceding clause (i), by
inserting ``and no component of an in vitro
clinical test or other article of in vitro
clinical test that requires further
processing,'' after ``health-related
purposes'';
(ii) in clause (i), by striking ``drug or
device'' and inserting ``drug, device, or in
vitro clinical test''; and
(iii) in clause (i)(I), by inserting ``in
vitro clinical test,'' after ``device,''; and
(B) in subparagraph (B), by inserting ``in vitro
clinical test,'' after ``device,''; and
(3) in subsection (e)(1), by inserting ``in vitro clinical
test,'' after ``device,''.
(n) Office of International Relations.--Section 803 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 383) is amended--
(1) in subsection (b)--
(A) in the matter preceding paragraph (1), by
inserting ``and in vitro clinical tests'' after
``devices''; and
(B) in paragraph (1), by inserting ``quality
requirements established under section 587J; and'' at
the end; and
(2) in subsection (c)--
(A) in paragraph (2), by inserting ``in vitro
clinical tests,'' after ``devices,''; and
(B) in paragraph (4), by inserting ``or in vitro
clinical tests'' after ``devices''.
(o) Recognition of Foreign Government Inspections.--Section
809(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
384e(a)(1)) is amended by inserting ``, or section 587I'' after
``510(h)''.
(p) Food and Drug Administration.--Section 1003(b)(2) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393(b)(2)) is amended--
(1) in subparagraph (D), by striking ``and'' at the end;
(2) in subparagraph (E), by striking the semicolon at the
end and inserting ``; and''; and
(3) by adding at the end the following:
``(F) in vitro clinical tests are analytically and
clinically valid;''.
(q) Office of Women's Health.--Section 1011(b) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 399b(b)) is amended--
(1) in paragraph (1), by inserting ``in vitro clinical
tests,'' after ``devices,''; and
(2) in paragraph (4), by striking ``and device
manufacturers'' and inserting ``device manufacturers, and in
vitro clinical test developers,''.
(r) Countermeasure Provisions of the PHSA.--Title III of the PHSA
is amended--
(1) in section 319F-2(c)(1)(B) (42 U.S.C. 247d-6b(c)(1)(B))
is amended--
(A) by striking ``or device'' and inserting
``device''; and
(B) by inserting ``or an in vitro clinical test (as
that term is defined in section 201(ss) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321(ss)))''
after ``Act (21 U.S.C. 321(h)))'';
(2) in section 319F-1(a)(2) (42 U.S.C. 247d-6a(a)(2)), by
inserting ``an in vitro clinical tests (as that term is defined
in section 201(ss) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 321(ss))),'' before ``or device''; and
(3) in section 319F-3(i)(7) (42 U.S.C. 247d-6d(i)(7)), by
inserting ``an in vitro clinical tests (as that term is defined
in section 201(ss) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 321(ss))),'' before ``or device''.
SEC. 5. TRANSITION.
(a) Implementation.--
(1) Effective date.--
(A) In general.--Except as otherwise provided in
this section, the amendments made by this Act apply 4
years after the date of enactment of this Act (in this
section and in subchapter J of chapter V of the Federal
Food, Drug, and Cosmetic Act, as added by this Act,
referred to in this section as the ``effective date of
this Act'').
(B) Exception.--The Secretary of Health and Human
Services (in this section referred to as the
``Secretary'') may take the actions described in
paragraph (2), and may expend such funds as the
Secretary determines necessary to ensure an orderly
transition.
(2) Actions.--The Secretary shall, prior to the date on
which the amendments made by this Act generally apply pursuant
to paragraph (1)--
(A) within 1 year of the date of enactment of this
Act hold the public meetings described in subchapter J
of chapter V of the Federal Food, Drug, and Cosmetic
Act, as added by section 3;
(B) within 2 years of the date of enactment of this
Act promulgate final regulations required under
sections 587B, 587D, 587L, 587M, 587V, and 587W; and
(C) within 2 years of the date of enactment of this
Act issue final guidance on applicability requirements
under section 587A.
(3) Applicability of regulations.--Notwithstanding the date
on which guidance or regulations are issued under paragraph
(2), no guidance or regulations issued pursuant to the
amendments made by this Act shall take effect until the
effective date of this Act, as described in paragraph (1),
except as otherwise provided for transitional tests under this
section.
(b) Application of Authorities to In Vitro Clinical Tests Until and
After Effective Date of This Act.--Except as provided in subsections
(c) and (d), for any in vitro clinical test as defined in section
201(ss) of the Federal Food, Drug, and Cosmetic Act, as added by this
Act, the following authorities shall apply:
(1) Tests offered prior to enactment.--An in vitro clinical
test that meets the criteria for a grandfathered test as set
forth in section 587A(c)(2) of the Federal Food, Drug, and
Cosmetic Act, as added by section 3, may continue to be offered
for clinical use and shall be subject only to applicable
provisions of section 353 of the Public Health Service Act and
section 587A(a)(4) of the Federal Food, Drug, and Cosmetic Act,
as added by section 3.
(2) Tests approved or cleared on or after the date of
enactment but prior to the effective date.--Before any in vitro
clinical test as defined in section 201(ss) of the Federal
Food, Drug, and Cosmetic Act, as added by this Act, is first
offered, sold, or distributed after the date of enactment of
this Act, but prior to the effective date of this Act, such
product or test shall be considered a transitional test as
described under subsection (c) and comply with the applicable
device provisions of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 301 et seq.) and the Public Health Service Act (42
U.S.C. 201 et seq.).
(3) Tests under fda review beginning on or after the date
of enactment of this act but prior to implementation.--For any
in vitro clinical test as defined in section 201(ss) of the
Federal Food, Drug, and Cosmetic Act, as added by this Act, for
which a submission for marketing authorization under section
515, clearance under section 510(k), authorization under
section 513(f)(2), approval under section 520(m), or emergency
use authorization under section 564 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360e, 360(k), 360c(f)(2), 360j(m),
360bbb-3) or approval under the Public Health Service Act (42
U.S.C. 201 et seq.) is pending on the effective date of this
Act, the Secretary may review and take action on such
submission after the effective date of this Act according to
the statutory provision under which such submission was
submitted.
(c) Application of Authorities to Transitional and Grandfathered In
Vitro Clinical Tests.--
(1) Definition.--For purposes of this section, the term
``transitional in vitro clinical test'' means an in vitro
clinical test, as defined in section 201(ss) of the Federal
Food, Drug, and Cosmetic Act, as added by this Act, that--
(A) is offered for clinical use during the period
beginning on the date of enactment of this Act and
ending on the date that is 90 days after the effective
date of this Act;
(B) is developed by a clinical laboratory certified
by the Secretary under section 353 of the Public Health
Service Act (42 U.S.C. 263a) that meets the
requirements for performing high-complexity testing for
use only within that certified laboratory or another
laboratory within the organization under common
ownership; and
(C) is not approved under section 515, cleared
under section 510(k), authorized under section
513(f)(2), subject to an exemption under section
520(m), or authorized under section 564 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360e, 360(k),
360c(f)(2), 360j(m), 360bbb-3) or approval under the
Public Health Service Act (42 U.S.C. 201 et seq.).
(2) Premarket review or technology certification.--A
transitional in vitro clinical test that is the subject of an
application for premarket review under section 587B of the
Federal Food, Drug, and Cosmetic Act or technology
certification application under section 587D of such Act, as
added by this Act, that is submitted prior to the effective
date of this Act may continue to be offered, sold, or
distributed until completion of the Secretary's review of the
premarket application or technology certification application.
(d) Conversion.--
(1) Deemed premarket approval.--Any in vitro clinical test
(as defined in section 201(ss) of the Federal Food, Drug, and
Cosmetic Act, as added by this Act) with a premarket approval
under section 515, a clearance under section 510(k), an
authorization under section 513(f), or a licensure under
section 351 of the Public Health Service Act (42 U.S.C. 262) is
deemed to have an approved application under section 587B of
the Federal Food, Drug, and Cosmetic Act, as added by this Act,
beginning on the later of--
(A) the effective date of this Act; or
(B) such other date, not later than 3 years after
such effective date, as the person responsible for the
device selects.
(2) Deemed investigational use approval.--Any in vitro
clinical test (as defined in section 201(ss) of the Federal
Food, Drug, and Cosmetic Act, as added by this Act) that has an
approved investigational device exemption under section 520(g)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(g))
is deemed to have an approved investigational use under section
587Q of such Act, as added by this Act, beginning on the
effective date of this Act.
(e) Instruments.--An instrument (as defined in section 587 of the
Federal Food, Drug, and Cosmetic Act, as added by this Act) that was
purchased prior to the date of enactment of this Act and was not
cleared, authorized, or approved by the Food and Drug Administration or
part of an instrument family that was cleared, authorized, or approved
by the Food and Drug Administration at the time of purchase may
continue to be used by the purchaser to develop and introduce into
interstate commerce an in vitro clinical test during the period
beginning on the date of enactment of this Act and ending 5 years after
such date of enactment. Beginning at the end of such period, any new in
vitro clinical test that is developed and introduced into interstate
commerce shall be based on an instrument (as defined in section 587(11)
of the Federal Food, Drug, and Cosmetic Act, as added by section 3)
that complies with the requirements of the Federal Food, Drug, and
Cosmetic Act, as amended by this Act.
(f) Relation to In Vitro Clinical Test Provision.--This section
applies notwithstanding section 587A(a)(1)(C) of the Federal Food,
Drug, and Cosmetic Act, as added by this Act.
SEC. 6. EMERGENCY USE AUTHORIZATION.
Section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360bbb-3) is amended--
(1) in paragraphs (1) and (4)(C) of subsection (a), by
inserting ``in vitro clinical test,'' before ``or biological
product'' each place such term appears; and
(2) in subsection (e)(3)--
(A) in subparagraph (B), by striking ``and'' at the
end;
(B) in subparagraph (C), by striking the period and
inserting ``; and''; and
(C) by adding at the end the following:
``(D) quality system requirements (with respect to
in vitro clinical tests) under section 587J.''.
SEC. 7. ANTIMICROBIAL SUSCEPTIBILITY TESTS.
Section 511A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360a-2) is amended--
(1) in subsection (a)(1)(C)--
(A) by striking ``or approve under section 515''
and inserting ``approve under section 515, or approve,
exempt, or issue a technology certification order under
subchapter J''; and
(B) by striking ``testing devices'' and inserting
``tests'';
(2) in subsection (c)(5), by striking ``drug or device''
each place it appears and inserting ``drug, device, or in vitro
clinical test'';
(3) in subsection (e)--
(A) in the heading, by striking ``Testing Devices''
and inserting ``In Vitro Clinical Tests'';
(B) in paragraph (1)--
(i) by striking ``and 515,'' and inserting
``515, 587B, and 587D'';
(ii) by striking ``antimicrobial
susceptibility testing device'' and inserting
``antimicrobial susceptibility in vitro
clinical test''; and
(iii) by striking ``such device'' and
inserting ``such test'';
(C) in paragraph (2)--
(i) in the heading, by striking ``testing
devices'' and inserting ``in vitro clinical
tests''; and
(ii) by amending subparagraph (C) to read
as follows:
``(C) The antimicrobial susceptibility in vitro
clinical test meets all other requirements to be
approved under section 587B or exempted from premarket
review under section 587D.''; and
(D) after making the amendments in subparagraphs
(B)(ii), (B)(iii), and (C)(ii), by striking ``device''
each place it appears and inserting ``in vitro clinical
test'';
(4) in subsection (f), by amending paragraph (1) to read as
follows:
``(1) The term `antimicrobial susceptibility in vitro
clinical test' means an in vitro clinical test that utilizes
susceptibility test interpretive criteria to determine and
report the in vitro susceptibility of certain microorganisms to
a drug (or drugs).''; and
(5) in subsection (g)(2)--
(A) by amending the matter preceding subparagraph
(A) to read as follows:
``(2) with respect to clearing under section 510(k),
classifying under section 513(f)(2), approving under section
515 or section 587B, or exempting from approval requirements
under section 587D--''; and
(B) in subparagraph (A)--
(i) by striking ``device'' and inserting
``in vitro clinical test''; and
(ii) by striking ``antimicrobial
susceptibility testing device'' and inserting
``antimicrobial susceptibility in vitro
clinical test''.
SEC. 8. COMBINATION PRODUCTS.
(a) In General.--Section 503(g) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 353(g)) is amended--
(1) in paragraph (1)--
(A) in subparagraph (A)--
(i) by inserting ``(except for a
combination product constituted of a device and
an in vitro clinical test)'' after ``agency
center,''; and
(ii) by inserting ``in vitro clinical
test,'' before ``or biological product''; and
(B) in subparagraph (D)--
(i) in the matter preceding clause (i), by
striking ``. If the Secretary determines'' and
inserting ``, except for a combination product
constituted of a device and an in vitro
clinical test. For other combination products,
if the Secretary determines''; and
(ii) in clause (ii)--
(I) by inserting ``or in vitro
clinical test'' after ``device''; and
(II) by inserting ``and in vitro
clinical tests'' before ``shall'';
(2) in paragraph (3), by striking ``safety and
effectiveness or substantial equivalence'' and inserting
``safety and effectiveness, substantial equivalence, or
analytical validity and clinical validity'' before ``for the
approved constituent part'';
(3) in paragraph (4)--
(A) in subparagraph (A), by striking ``or 513(f)(2)
(submitted in accordance with paragraph (5))'' and
inserting ``513(f)(2) (submitted in accordance with
paragraph (5)), 587B, or an exempt test under section
587A, as applicable''; and
(B) in subparagraph (B), by inserting ``or 587B''
after ``section 515'';
(4) in paragraph (5)(A), by striking ``or 510(k)'' and
inserting ``, 510(k), or 587B'';
(5) in paragraph (7), by striking ``or substantial
equivalence'' and inserting ``, substantial equivalence, or
analytical validity and clinical validity'';
(6) in paragraph (8), by adding at the end the following:
``(I) This paragraph shall not apply to a
combination product constituted of a device and an in
vitro clinical test.''; and
(7) in paragraph (9)--
(A) in subparagraph (C)(i), by striking ``or
520(g)'' and inserting ``520(g), or 587B''; and
(B) in subparagraph (D), by striking ``or 520'' and
inserting ``520, or 587B''.
(b) Classification of Products.--Section 563 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360bbb-2) is amended by adding at the
end the following:
``(d) Exemption.--This section shall not apply to a combination
product constituted of a device and an in vitro clinical test.''.
SEC. 9. RESOURCES.
(a) Findings.--Congress finds that the fees authorized by this
section will be dedicated to meeting the goals identified in the
letters from the Secretary of Health and Human Services to the
Committee on Health, Education, Labor, and Pensions of the Senate and
the Committee on Energy and Commerce of the House of Representatives,
as set forth in the Congressional Record.
(b) Establishment of User Fee Program.--
(1) Development of user fees for in vitro clinical tests.--
(A) In general.--Beginning not later than October
1, 2021, the Secretary of Health and Human Services (in
this section referred to as the ``Secretary'') shall
develop recommendations to present to Congress with
respect to the goals, and plans for meeting the goals,
for the process of the review of in vitro clinical test
applications submitted under subchapter J of chapter V
of the Federal Food, Drug, and Cosmetic Act, as added
by this Act, for the first 5 fiscal years after fiscal
year 2022. In developing such recommendations, the
Secretary shall consult with--
(i) the Committee on Energy and Commerce of
the House of Representatives;
(ii) the Committee on Health, Education,
Labor, and Pensions of the Senate;
(iii) scientific and academic experts;
(iv) health care professionals;
(v) representatives of patient and consumer
advocacy groups; and
(vi) the regulated industry.
(B) Prior public input.--Prior to beginning
negotiations with the regulated industry on the
authorization of such subchapter J, the Secretary
shall--
(i) publish a notice in the Federal
Register requesting public input on the
authorization of user fees;
(ii) hold a public meeting at which the
public may present its views on the
authorization, including specific suggestions
for the recommendations submitted under
subparagraph (E);
(iii) provide a period of 30 days after the
public meeting to obtain written comments from
the public suggesting changes to such
subchapter J; and
(iv) publish any comments received under
clause (iii) on the website of the Food and
Drug Administration.
(C) Periodic consultation.--Not less frequently
than once every month during negotiations with the
regulated industry, the Secretary shall hold
discussions with representatives of patient and
consumer advocacy groups to continue discussions of the
authorization under such subchapter J and to solicit
suggestions to be included in the recommendations
transmitted to Congress under subparagraph (E).
(D) Public review of recommendations.--After
negotiations with the regulated industry, the Secretary
shall--
(i) present the recommendations developed
under subparagraph (A) to the Committee on
Health, Education, Labor, and Pensions of the
Senate and the Committee on Energy and Commerce
of the House of Representatives;
(ii) publish such recommendations in the
Federal Register;
(iii) provide for a period of 30 days for
the public to provide written comments on such
recommendations;
(iv) hold a meeting at which the public may
present its views on such recommendations; and
(v) after consideration of such public
views and comments, revise such recommendations
as necessary.
(E) Transmittal of recommendations.--
(i) In general.--Not later than June 1,
2021, the Secretary shall transmit to Congress
the revised recommendations under subparagraph
(A), a summary of the views and comments
received under such subparagraph, and any
changes made to the recommendations in response
to such views and comments.
(ii) Recommendation requirements.--The
recommendations transmitted under this
subparagraph shall--
(I) include the number of full-time
equivalent employees per fiscal year
that are agreed to be hired to carry
out the goals included in such
recommendations for each year of the 5-
year period;
(II) provide that the amount of
operating reserve balance in the user
fee program established under this
section is not more than the equivalent
of 10 weeks of operating reserve;
(III) require the development of a
strategic plan for any surplus within
the operating reserve account above the
10-week operating reserve within 2
years of the establishment of the
program;
(IV) include an operating reserve
adjustment such that, if the Secretary
has an operating reserve balance in
excess of 10 weeks of such operating
reserves, the Secretary shall decrease
such fee revenue and fees to provide
for not more than 10 weeks of such
operating reserves;
(V) if an adjustment is made as
described in subclause (IV), provide
the rationale for the amount of the
decrease in fee revenue and fees shall
be contained in the Federal Register;
and
(VI) provide that the fees assessed
and collected for the full-time
equivalent employees at the Center for
Devices and Radiological Health, with
respect to which the majority of time
reporting data indicates are dedicated
to the review of in vitro clinical
tests, are not supported by the funds
authorized to be collected and assessed
under section 738 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C.
379j).
(F) Publication of recommendations.--The Secretary
shall publish on the website of the Food and Drug
Administration the revised recommendations under
subparagraph (A), a summary of the views and comments
received under subparagraphs (B) through (D), and any
changes made to the recommendations originally proposed
by the Secretary in response to such views and
comments.
(G) Minutes of negotiation meetings.--
(i) Public availability.--Before
transmitting the recommendations developed
under subparagraphs (A) through (F) to
Congress, the Secretary shall make publicly
available, on the website of the Food and Drug
Administration, minutes of all negotiation
meetings conducted under this subsection
between the Food and Drug Administration and
the regulated industry.
(ii) Content.--The minutes described under
clause (i) shall summarize any substantive
proposal made by any party to the negotiations,
any significant controversies or differences of
opinion during the negotiations, and the
resolution of any such controversy or
difference of opinion.
(2) Establishment of user fee program.--Effective on
October 1, 2021, provided that the Secretary transmits the
recommendations under paragraph (1)(E), the Secretary is
authorized to collect user fees relating to the submission of
in vitro clinical test applications submitted under subchapter
J of chapter V of the Federal Food, Drug, and Cosmetic Act, as
added by this Act. Fees under such program shall be assessed
and collected only if the requirements under paragraph (4) are
met.
(3) Audit.--
(A) In general.--On the date that is 2 years after
first receiving a user fee applicable to submission of
an in vitro clinical test application submitted under
subchapter J of chapter V of the Federal Food, Drug,
and Cosmetic Act, as added by this Act, and on a
biennial basis thereafter until October 1, 2027, the
Secretary shall perform an audit of the costs of
reviewing such applications under such subchapter J.
Such an audit shall compare the costs of reviewing such
applications under such subchapter J to the amount of
the user fee applicable to such applications.
(B) Alteration of user fee.--If the audit performed
under subparagraph (A) indicates that the user fees
applicable to applications submitted under such
subchapter J exceed 30 percent of the costs of
reviewing such applications, the Secretary shall alter
the user fees applicable to applications submitted
under such subchapter J such that the user fees do not
exceed such percentage.
(C) Accounting standards.--The Secretary shall
perform an audit under subparagraph (A) in conformance
with the accounting principles, standards, and
requirements prescribed by the Comptroller General of
the United States under section 3511 of title 31,
United States Code, to ensure the validity of any
potential variability.
(4) Conditions.--The user fee program described in this
subsection shall take effect only if the Food and Drug
Administration issues draft guidance related to the review
requirements for in vitro diagnostic tests that would be
subject to premarket review under section 587B of the Federal
Food, Drug, and Cosmetic Act, as added by section 3, the review
requirements for test categories eligible for technology
certification under section 587D of such Act, as added by
section 3, and the parameters for the test categories that
would be exempt from any review under subchapter J of chapter V
of such Act.
(5) User fee program definitions and resource
requirements.--
(A) In general.--The term ``process for the review
of in vitro clinical test applications'' means the
following activities of the Secretary with respect to
the review of premarket applications under section 587B
of the Federal Food, Drug, and Cosmetic Act (as added
by section 3), technology certification applications
under section 587D of such Act (as added by section 3),
and supplements for such applications:
(i) The activities necessary for the review
of premarket applications, premarket reports,
and supplements to such applications.
(ii) The issuance of action letters that
allow the marketing of in vitro clinical tests
or which set forth in detail the specific
deficiencies in such applications, reports,
supplements, or submissions and, where
appropriate, the actions necessary to place
them in condition for approval.
(iii) The inspection of manufacturing
establishments and other facilities undertaken
as part of the Secretary's review of pending
premarket applications, technology
certifications, and supplements.
(iv) Monitoring of research conducted in
connection with the review of such
applications, supplements, and submissions.
(v) Review of in vitro clinical test
applications subject to section 351 of the
Public Health Service Act (42 U.S.C. 262),
investigational new drug applications under
section 505(i) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(i)), or
investigational test exemptions under section
587A(m) of the Federal Food, Drug, and Cosmetic
Act (as added by section 3), and activities
conducted in anticipation of the submission of
such applications under section 505(i) of the
Federal Food, Drug, and Cosmetic Act or
investigational use under section 587R of the
Federal Food, Drug, and Cosmetic Act (as added
by section 3).
(vi) The development of guidance, policy
documents, or regulations to improve the
process for the review of premarket
applications, technology certification
applications, and supplements.
(vii) The development of voluntary test
methods, consensus standards, or mandatory
performance standards in connection with the
review of such applications, supplements, or
submissions and related activities.
(viii) The provision of technical
assistance to in vitro clinical test developers
in connection with the submission of such
applications, reports, supplements, or
submissions.
(ix) Any activity undertaken in connection
with the initial classification or
reclassification of an in vitro clinical test
in connection with any requirement for approval
of an in vitro clinical test.
(x) Evaluation of postmarket studies
required as a condition of an approval of a
premarket application of an in vitro clinical
test.
(xi) Compiling, developing, and reviewing
information on relevant in vitro clinical tests
to identify issues with the applicable standard
for premarket applications, technology
certification applications, and supplements.
(B) Resource requirements.--Fees collected and
assessed under this section shall be used for the
process for the review of in vitro clinical test
applications, as described in subparagraph (A), and
shall--
(i) be subject to the limitation under
section 738(g)(3) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379j(g)(3)), in the
same manner that fees collected and assessed
under section 737(9)(C) of such Act (21 U.S.C.
379i(9)(C)) are subject to such limitation;
(ii) include travel expenses for officers
and employees of the Food and Drug
Administration only if the Secretary determines
that such travel is directly related to an
activity described in subparagraph (A); and
(iii) not be allocated to purposes
described under section 722(a) of the
Consolidated Appropriations Act, 2018 (Public
Law 115-141).
(c) Reports.--
(1) Performance report.--
(A) In general.--
(i) General requirements.--Beginning with
fiscal year 2021, for each fiscal year for
which fees are collected under this section,
the Secretary shall prepare and submit to the
Committee on Health, Education, Labor, and
Pensions of the Senate and the Committee on
Energy and Commerce of the House of
Representatives annual reports concerning the
progress of the Food and Drug Administration in
achieving the goals identified in the
recommendations transmitted to Congress by the
Secretary pursuant to subsection (b)(1)(E)
during such fiscal year and the future plans of
the Food and Drug Administration for meeting
the goals.
(ii) Additional information.--Beginning
with fiscal year 2021, the annual report under
this subparagraph shall include the progress of
the Food and Drug Administration in achieving
the goals, and future plans for meeting the
goals, including--
(I) the number of premarket
applications filed under section 587B
of the Federal Food, Drug, and Cosmetic
Act during the applicable fiscal year;
(II) the number of technology
certification applications submitted
under section 587D of the Federal Food,
Drug, and Cosmetic Act during the
applicable fiscal year for each review
division; and
(III) the number of breakthrough
designations under section 587C of the
Federal Food, Drug, and Cosmetic Act
during the applicable fiscal year.
(iii) Real-time reporting.--
(I) In general.--Not later than 30
calendar days after the end of the
second quarter of fiscal year 2021, and
not later than 30 calendar days after
the end of each quarter of each fiscal
year thereafter, the Secretary shall
post the data described in subclause
(II) on the website of the Food and
Drug Administration for such quarter
and on a cumulative basis for such
fiscal year, and may remove duplicative
data from the annual report under this
subparagraph.
(II) Data.--The Secretary shall
post the following data in accordance
with subclause (I):
(aa) The number and titles
of draft and final guidance on
topics related to the process
for the review of in vitro
clinical tests, and whether
such guidances were issued as
required by statute or pursuant
to the recommendations
transmitted to Congress by the
Secretary pursuant to
subsection (b)(1)(E).
(bb) The number and titles
of public meetings held on
topics related to the process
for the review of in vitro
clinical tests, and if such
meetings were required by
statute or pursuant to the
recommendations transmitted to
Congress by the Secretary
pursuant to subsection
(b)(1)(E).
(iv) Rationale for ivct user fee program
changes.--Beginning with fiscal year 2022, the
Secretary shall include in the annual
performance report under paragraph (1)--
(I) data, analysis, and discussion
of the changes in the number of full-
time equivalents hired as agreed upon
in the recommendations transmitted to
Congress by the Secretary pursuant to
subsection (b)(1)(E) and the number of
full-time equivalents funded by budget
authority at the Food and Drug
Administration by each division within
the Center for Devices and Radiological
Health, the Center for Biologics
Evaluation and Research, the Office of
Regulatory Affairs, and the Office of
the Commissioner;
(II) data, analysis, and discussion
of the changes in the fee revenue
amounts and costs for the process for
the review of in vitro clinical tests,
including identifying drivers of such
changes; and
(III) for each of the Center for
Devices and Radiological Health, the
Center for Biologics Evaluation and
Research, the Office of Regulatory
Affairs, and the Office of the
Commissioner, the number of employees
for whom time reporting is required and
the number of employees for whom time
reporting is not required.
(v) Analysis.--For each fiscal year, the
Secretary shall include in the report under
clause (i) an analysis of the following:
(I) The difference between the
aggregate number of premarket
applications filed under section 587B
or section 587D of the Federal Food,
Drug, and Cosmetic Act and the
aggregate number of major deficiency
letters, not approvable letters, and
denials for such applications issued by
the agency, accounting for--
(aa) the number of
applications filed under each
of sections 587B and 587D of
the Federal Food, Drug, and
Cosmetic Act during one fiscal
year for which a decision is
not scheduled to be made until
the following fiscal year; and
(bb) the aggregate number
of applications under each of
sections 587B and 587D of the
Federal Food, Drug, and
Cosmetic Act for each fiscal
year that did not meet the
goals as identified by the
recommendations transmitted to
Congress by the Secretary
pursuant to subsection
(b)(1)(E).
(II) Relevant data to determine
whether the Center for Devices and
Radiological Health has met performance
enhancement goals identified by the
recommendations transmitted to Congress
by the Secretary pursuant to subsection
(b)(1)(E).
(III) The most common causes and
trends for external or other
circumstances affecting the ability of
the Food and Drug Administration to
meet review time and performance
enhancement goals identified by the
recommendations transmitted to Congress
by the Secretary pursuant to subsection
(b)(1)(E).
(B) Publication.--With regard to information to be
reported by the Food and Drug Administration to
industry on a quarterly and annual basis pursuant to
recommendations transmitted to Congress by the
Secretary pursuant to subsection (b)(1)(E), the
Secretary shall make such information publicly
available on the website of the Food and Drug
Administration not later than 60 days after the end of
each quarter or 120 days after the end of each fiscal
year, respectively, to which such information applies.
(C) Updates.--The Secretary shall include in each
report under subparagraph (A) information on all
previous cohorts for which the Secretary has not given
a complete response on all in vitro clinical test
premarket applications and technology certification
orders and supplements, premarket, and technology
certification notifications in the cohort.
(2) Corrective action report.--Beginning with fiscal year
2022, for each fiscal year for which fees are collected under
this section, the Secretary shall prepare and submit a
corrective action report to the Committee on Health, Education,
Labor, and Pensions and the Committee on Appropriations of the
Senate and the Committee on Energy and Commerce and the
Committee on Appropriations of the House of Representatives.
The report shall include the following information, as
applicable:
(A) Goals met.--For each fiscal year, if the
Secretary determines, based on the analysis under
paragraph (1)(A)(v), that each of the goals identified
by the recommendations transmitted to Congress by the
Secretary pursuant to subsection (b)(1)(E) for the
applicable fiscal year have been met, the corrective
action report shall include recommendations on ways in
which the Secretary can improve and streamline the in
vitro clinical test premarket application and
technology certification review process.
(B) Goals missed.--For each of the goals identified
by the letters described in recommendations transmitted
to Congress by the Secretary pursuant to subsection
(b)(1)(E) for the applicable fiscal year that the
Secretary determines to not have been met, the
corrective action report shall include--
(i) a justification for such determination;
(ii) a description of the types of
circumstances, in the aggregate, under which
applications or reports submitted under
sections 587B and 587D of the Federal Food,
Drug, and Cosmetic Act missed the review goal
times but were approved during the first cycle
review, as applicable;
(iii) a summary and any trends with regard
to the circumstances for which a review goal
was missed; and
(iv) the performance enhancement goals that
were not achieved during the previous fiscal
year and a description of efforts the Food and
Drug Administration has put in place for the
fiscal year in which the report is submitted to
improve the ability of such agency to meet each
such goal for the such fiscal year.
(3) Fiscal report.--For fiscal years 2021 and annually
thereafter, not later than 120 days after the end of each
fiscal year during which fees are collected under this subpart,
the Secretary shall prepare and submit to the Committee on
Health, Education, Labor, and Pensions of the Senate and the
Committee on Energy and Commerce of the House of
Representatives, a report on the implementation of the
authority for such fees during such fiscal year and the use, by
the Food and Drug Administration, of the fees collected during
such fiscal year for which the report is made.
(A) Contents.--Such report shall include
expenditures delineated by budget authority and user
fee dollars related to administrative expenses and
information technology infrastructure contracts and
expenditures.
(B) Operating reserve.--Such report shall provide
the amount of operating reserve balance available each
year, and any planned allocations or obligations of
such balance that is above 10 weeks of operating
reserve for the program.
(4) Public availability.--The Secretary shall make the
reports required under paragraphs (1) through (3) available to
the public on the website of the Food and Drug Administration.
(5) Enhanced communication.--
(A) Communications with congress.--Each fiscal
year, as applicable and requested, representatives from
the Centers with expertise in the review of in vitro
clinical tests shall meet with representatives from the
Committee on Health, Education, Labor, and Pensions of
the Senate and the Committee on Energy and Commerce of
the House of Representatives to report on the contents
described in the reports under this section.
(B) Participation in congressional hearing.--Each
fiscal year, as applicable and requested,
representatives from the Food and Drug Administration
shall participate in a public hearing before the
Committee on Health, Education, Labor, and Pensions of
the Senate and the Committee on Energy and Commerce of
the House of Representatives, to report on the contents
described in the reports under this section. Such
hearing shall occur not later than 120 days after the
end of each fiscal year for which fees are collected
under this section.
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