[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 2187 Introduced in Senate (IS)]
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114th CONGRESS
1st Session
S. 2187
To establish a third-party quality system assessment program.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
October 21, 2015
Mr. Donnelly (for himself and Mr. Gardner) introduced the following
bill; which was read twice and referred to the Committee on Health,
Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To establish a third-party quality system assessment program.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``FDA Regulatory Efficiency Act''.
SEC. 2. THIRD-PARTY QUALITY SYSTEM ASSESSMENT.
(a) Establishment of Third-Party Quality System Assessment
Program.--Chapter V of the Federal Food, Drug, and Cosmetic Act is
amended by inserting after section 524A (21 U.S.C. 360n-1) the
following:
``SEC. 524B. THIRD-PARTY QUALITY SYSTEM ASSESSMENT.
``(a) Accreditation and Assessment.--
``(1) In general; certification of device quality system.--
The Secretary shall, in accordance with this section, establish
a third-party quality system assessment program--
``(A) to accredit persons to assess whether a
requestor's quality system, including its design
controls, can reasonably assure the safety and
effectiveness of in-scope devices subject to device-
related changes;
``(B) under which accredited persons shall (as
applicable) certify that a requestor's quality system
meets the criteria included in the guidance issued
under paragraph (5) with respect to the in-scope
devices at issue; and
``(C) under which the Secretary shall rely on such
certifications for purposes of determining the safety
and effectiveness (or as applicable, substantial
equivalence) of in-scope devices subject to the device-
related changes involved, in lieu of compliance with
the following submission requirements:
``(i) A premarket notification.
``(ii) A 30-day notice.
``(iii) A Special PMA supplement.
``(2) Definitions.--For purposes of this section--
``(A) the term `device-related changes' means
changes made by a requestor with respect to in-scope
devices, which are--
``(i) changes to a device found to be
substantially equivalent under subsections
(f)(1) and (i) of section 513 to a predicate
device, that--
``(I) would otherwise be subject to
a premarket notification; and
``(II) do not alter--
``(aa) the intended use of
the changed device; or
``(bb) the fundamental
scientific technology of such
device;
``(ii) manufacturing changes subject to a
30-day notice;
``(iii) changes that qualify for a Special
PMA Supplement; and
``(iv) such other changes relating to the
devices or the device manufacturing process as
the Secretary determines appropriate;
``(B) the term `in-scope device' means a device
within the scope of devices agreed to by the requestor
and the accredited person for purposes of a request for
certification under this section;
``(C) the term `premarket notification' means a
premarket notification under section 510(k);
``(D) the term `quality system' means the methods
used in, and the facilities and controls used for, the
design, manufacture, packaging, labeling, storage,
installation, and servicing of devices, as described in
section 520(f);
``(E) the term `requestor' means a device
manufacturer that is seeking certification under this
section of a quality system used by such manufacturer;
``(F) the term `Special PMA' means a PMA supplement
under section 814.39(d) of title 21, Code of Federal
Regulations (or any successor regulations); and
``(G) the term `30-day notice' means a notice
described in section 515(d)(6).
``(3) Accreditation process; accreditation renewal.--Except
as inconsistent with this section, the process and
qualifications for accreditation of persons and renewal of such
accreditation under section 704(g) shall apply with respect to
accreditation of persons and renewal of such accreditation
under this section.
``(4) Use of accredited parties to conduct assessments.--
``(A) Initiation of assessment services.--
``(i) Date assessments authorized.--
Beginning after the date on which the final
guidance is issued under paragraph (5), an
accredited person may conduct an assessment
under this section.
``(ii) Initiation of assessments.--Use of
one or more accredited persons to assess a
requestor's quality system under this section
with respect to in-scope devices shall be at
the initiation of the person who registers and
lists the devices at issue under section 510.
``(B) Compensation.--Compensation for such
accredited persons shall--
``(i) be determined by agreement between
the accredited person and the person who
engages the services of the accredited person;
and
``(ii) be paid by the person who engages
such services.
``(C) Accredited person selection.--Each person who
chooses to use an accredited person to assess a
requestor's quality system, as described in this
section, shall select the accredited person from a list
of such persons published by the Secretary in
accordance with section 704(g)(4).
``(5) Guidance; criteria for certification.--
``(A) In general.--The criteria for certification
of a quality system under this section shall be as
specified by the Secretary in guidance issued under
this paragraph.
``(B) Contents; criteria.--The guidance under this
paragraph shall include specification of--
``(i) evaluative criteria to be used by an
accredited person to assess and, as applicable,
certify a requestor's quality system under this
section with respect to in-scope devices; and
``(ii) criteria for accredited persons to
apply for a waiver of, and exemptions from, the
criteria under clause (i).
``(C) Timeframe for issuing guidance.--The
Secretary shall issue under this paragraph--
``(i) draft guidance not later than 12
months after the enactment of the FDA
Regulatory Efficiency Act; and
``(ii) final guidance not later than 12
months after issuance of the draft guidance
under clause (i).
``(b) Use of Third-Party Assessment.--
``(1) Assessment summary; certification.--
``(A) Submission of assessment to secretary.--An
accredited person who assesses a requestor's quality
system under subsection (a) shall submit to the
Secretary a summary of the assessment--
``(i) within 30 days of the assessment; and
``(ii) which shall include (as
applicable)--
``(I) the accredited person's
certification that the requestor has
satisfied the criteria specified in the
guidance issued under subsection (a)(5)
for quality system certification with
respect to the in-scope devices at
issue; and
``(II) any waivers or exemptions
from such criteria applied by the
accredited person.
``(B) Treatment of assessments.--Subject to action
by the Secretary under subparagraph (C), with respect
to assessments which include a certification under this
section--
``(i) the Secretary's review of the
assessment summary shall be deemed complete on
the day that is 30 days after the date on which
the Secretary receives the summary under
subparagraph (A); and
``(ii) the assessment summary and
certification of the quality system of a
requestor shall be deemed accepted by the
Secretary on such 30th day.
``(C) Actions by secretary.--
``(i) In general.--Within 30 days of
receiving an assessment summary and
certification under subparagraph (A), the
Secretary may, by written notice to the
accredited person submitting such assessment
certification, deem any such certification to
be provisional beyond such 30-day period,
suspended pending further review by the
Secretary, or otherwise qualified or cancelled,
based on the Secretary's determination that (as
applicable)--
``(I) additional information is
needed to support such certification;
``(II) such assessment or
certification is unwarranted; or
``(III) such action with regard to
the certification is otherwise
justified according to such factors and
criteria as the Secretary finds
appropriate.
``(ii) Acceptance of certification.--If
following action by the Secretary under clause
(i) with respect to a certification, the
Secretary determines that such certification is
acceptable, the Secretary shall issue written
notice to the applicable accredited person
indicating such acceptance.
``(2) Notifications to secretary by certified requestors or
accredited persons for program evaluation purposes.--
``(A) Annual summary report for device-related
changes otherwise subject to premarket notification.--A
requestor whose quality system is certified under this
section that effectuates device-related changes with
respect to in-scope devices, without prior submission
of a premarket notification, shall ensure that an
annual summary report is submitted to the Secretary by
the accredited person which--
``(i) describes the changes made to the in-
scope device; and
``(ii) indicates the effective dates of
such changes.
``(B) Periodic notification for manufacturing
changes otherwise subject to 30-day notice.--A
requestor whose quality system is certified under this
section that effectuates device-related changes with
respect to in-scope devices, without prior submission
of a 30-day notice, shall provide notification to the
Secretary of such changes in the requestor's next
periodic report under section 814.84(b) of title 21,
Code of Federal Regulations (or any successor
regulation). Such notification shall--
``(i) describe the changes made; and
``(ii) indicate the effective dates of such
changes.
``(C) Periodic notification for device-related
changes otherwise subject to special pma supplement.--A
requestor whose quality system is certified under this
section that effectuates device-related changes with
respect to in-scope devices, without prior submission
of a Special PMA Supplement, shall provide notification
to the Secretary of such changes in the requestor's
next periodic report under section 814.84(b) of title
21, Code of Federal Regulations (or any successor
regulation). Such notification shall--
``(i) describe the changes made, including
a full explanation of the basis for the
changes; and
``(ii) indicate the effective dates of such
changes.
``(D) Use of notifications for program evaluation
purposes.--Information submitted to the Secretary under
subparagraphs (A) through (C) shall be used by the
Secretary for purposes of the program evaluation under
subsection (d).
``(c) Duration and Effect of Certification.--A certification under
this section--
``(1) shall remain in effect for a period of 2 years from
the date such certification is accepted by the Secretary,
subject to paragraph (6);
``(2) may be renewed through the process described in
subsection (a)(3);
``(3) shall continue to apply with respect to device-
related changes made during such 2-year period, provided the
certification remains in effect, irrespective of whether such
certification is renewed after such 2-year period;
``(4) shall have no effect on the need to comply with
applicable submission requirements specified in subsection
(a)(1)(C) with respect to any change pertaining to in-scope
devices which is not a device-related change under subsection
(a)(2);
``(5) shall have no effect on the authority of the
Secretary to conduct an inspection or otherwise determine
whether the requestor has complied with the applicable
requirements of this Act; and
``(6) may be revoked by the Secretary upon a determination
that the requestor's quality system no longer meets the
criteria specified in the guidance issued under subsection
(a)(5) with respect to the in-scope devices at issue.
``(d) Notice of Revocation.--The Secretary shall provide written
notification to the requestor of a revocation pursuant to subsection
(c)(6) not later than 10 business days after the determination
described in such subsection. Upon receipt of the written notification,
the requestor shall satisfy the applicable submission requirements
specified in subsection (a)(1)(C) for any device-related changes
effectuated after the date of such determination. After such
revocation, such requestor is eligible to seek re-certification under
this section of its quality system.
``(e) Program Evaluation; Sunset.--
``(1) Program evaluation and report.--
``(A) Evaluation.--The Secretary shall complete an
evaluation of the third-party quality system assessment
program under this section no later than January 31,
2021, based on--
``(i) analysis of information from a
representative group of device manufacturers
obtained from notifications provided by
certified requestors or accredited persons
under subsection (b)(2); and
``(ii) such other available information and
data as the Secretary determines appropriate.
``(B) Report.--No later than 1 year after
completing the evaluation under subparagraph (A), the
Secretary shall issue a report of the evaluation's
findings on the website of the Food and Drug
Administration, which shall include the Secretary's
recommendations with respect to continuation and as
applicable expansion of the program under this section
to encompass--
``(i) device submissions beyond those
identified in subsection (a)(1)(C); and
``(ii) device changes beyond those
described in subsection (a)(2)(A).
``(2) Sunset.--This section shall cease to be effective
October 1, 2022.
``(f) Rule of Construction.--Nothing in this section shall be
construed to limit the authority of the Secretary to request and review
the complete assessment of a certified requestor under this section on
a for-cause basis.''.
(b) Conforming Amendments.--
(1) Requirements for premarket approval supplements.--
Section 515(d)(6)(A)(i) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360e(d)(5)(A)(i)) is amended by inserting
``subject to section 524B,'' after ``that affects safety or
effectiveness,''.
(2) Requirements for 30-day notice.--Section
515(d)(6)(A)(ii) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360e(d)(5)(A)(ii)) is amended by inserting ``subject
to section 524B,'' after ``the date on which the Secretary
receives the notice,''.
(3) Requirements for premarket notification; technical
correction to reference to section 510(k).--Section 510(l) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(l)) is
amended by striking ``of this subsection under subsection (m)''
and inserting ``of subsection (k) under subsection (m) or
section 524B''.
(4) Misbranded devices.--Section 502(t) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 352(t)) is amended by
inserting ``or 524B'' after ``section 519''.
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