[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3209 Introduced in House (IH)]
112th CONGRESS
1st Session
H. R. 3209
To amend the Federal Food, Drug, and Cosmetic Act to provide
predictability, consistency, and transparency to the premarket review
process.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
October 14, 2011
Mr. Shimkus (for himself, Mr. Gingrey of Georgia, Mr. Guthrie, Mr.
Altmire, Mr. Lance, Mrs. Blackburn, Mr. Rogers of Michigan, Mr.
Bilbray, Mr. Burgess, Mr. Barton of Texas, Mr. Paulsen, Mr. Cassidy,
and Mr. Latta) introduced the following bill; which was referred to the
Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to provide
predictability, consistency, and transparency to the premarket review
process.
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 ``Premarket Predictability Act of
2011''.
SEC. 2. TRACKING AND REVIEW OF APPLICATIONS FOR INVESTIGATIONAL DEVICE
EXEMPTIONS.
Section 520(g) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360j(g)) is amended by adding at the end the following:
``(8)(A) Upon the submission of an application for an exemption for
a device under this subsection, the submission of a request to classify
a device under section 513, or the submission of a report for a device
under section 510(k), whichever occurs first, the Secretary shall
assign a tracking number to the device.
``(B) The Secretary shall use such tracking number to record the
following interactions between the Secretary and applicant with respect
to the device:
``(i) Submission or approval of an application for an
exemption under this subsection.
``(ii) Submission or clearance of a report under section
510(k).
``(iii) Any meeting or meeting request, including in
anticipation of the submission of such an application or
report.
``(iv) Submission or approval of an application under
section 515(c).
``(v) Any formal or informal request by the Secretary for
additional information.
``(vi) Any deficiency letter.
``(vii) Any response by the applicant to a request
described in clause (v) or a deficiency letter.
``(viii) Any written submission by the applicant to the
Food and Drug Administration.
``(ix) Any other matter, as determined appropriate by the
Secretary.
``(9) Upon the submission of an application for an exemption under
this subsection for a device, the Secretary shall assign, to review the
application, a reviewer with prior review experience with that type of
device or technology or other relevant expertise.''.
SEC. 3. OTHER RULES RELATING TO INVESTIGATIONAL DEVICE EXEMPTIONS.
Section 520(g) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360j(g)) is amended--
(1) in paragraph (2)(A), by adding at the end the
following: ``Procedures and conditions pursuant to the
preceding sentence shall require the Secretary, in determining
whether to grant such an exemption, to evaluate whether the
investigational study can be conducted ethically and with
reasonable risk.'';
(2) in paragraph (2)(B)(ii), by striking ``evaluate the
safety and effectiveness of the device'' and inserting
``evaluate whether the investigational study is being conducted
ethically and with reasonable risk'';
(3) in paragraph (4)(B), by adding at the end the
following: ``The Secretary may not disapprove an application
because the investigation does not or may not meet any
requirement, including a data requirement, relating to the
approval or clearance of a device because the Secretary
believes that a different clinical testing design or plan could
produce data more relevant to an approval or clearance
decision.'';
(4) in paragraph (7)(A), by striking ``(7)(A) In the case''
and all that follows through the end paragraph (7)(A) and
inserting the following:
``(7)(A)(i) In the case of a person intending to investigate the
safety or effectiveness of a class II or a class III device, the
Secretary shall ensure that the person has an opportunity, prior to
submitting an application to the Secretary, to submit to the Secretary,
for review, an investigational plan (including a clinical protocol). If
the applicant submits a written request for a meeting with the
Secretary regarding such review, the Secretary shall, not later than 30
days after receiving the request, meet with the applicant for the
purpose of reaching agreement regarding the investigational plan
(including a clinical protocol). The written request shall include a
detailed description of the device, a detailed description of the
proposed conditions of use of the device, information (if available)
regarding the expected performance of the device, and a proposed plan
(including a clinical protocol) for determining--
``(I) whether there is a reasonable assurance of safety and
effectiveness; or
``(II) whether the device is substantially equivalent to or
is at least as safe and effective as a legally marketed device
that is not subject to approval requirements under section 515.
``(ii) In the case where the Secretary fails to meet the applicant
not later than 30 days after receiving a request as described under
clause (i), the proposed plan submitted in such request shall be deemed
to be the agreement reached between the Secretary and the applicant
under subparagraph (B) and such agreement shall not be subject to
change except as provided in subparagraph (B).''; and
(5) in paragraph (7)(B)(ii), by inserting ``that has
emerged since the date of the agreement and that is'' after
``substantial scientific issue''.
SEC. 4. CLARIFICATION OF LEAST BURDENSOME STANDARD.
(a) Premarket Approval.--Section 513(a)(3)(D) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360c(a)(3)(D)) is amended--
(1) by redesignating clause (iii) as clause (iv); and
(2) by inserting after clause (ii) the following:
``(iii) In carrying out clause (ii), the Secretary--
``(I) shall not request information unrelated or irrelevant
to a demonstration of reasonable assurance of device
effectiveness;
``(II) shall consider alternative approaches to evaluating
device effectiveness in order to reduce the time, effort, and
cost of reaching proper resolution of the issue;
``(III) shall use all reasonable mechanisms to lessen
review times and render regulatory decisions;
``(IV) shall consider whether pre-clinical data, such as
well-designed bench and animal testing, can meet the statutory
threshold for approval; and
``(V) if clinical data are needed, shall consider
alternatives to randomized, controlled clinical trials and the
use of surrogate endpoints.''.
(b) Substantial Equivalence Determination.--Section 513(i)(1)(D) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(i)(1)(D)) is
amended--
(1) by striking ``(D) Whenever'' and inserting ``(D)(i)
Whenever''; and
(2) by adding at the end the following:
``(ii) In carrying out clause (i), the Secretary--
``(I) shall focus on whether there is a reasonable
assurance that the device is safe and effective for its
intended use;
``(II) shall not request or accept information unrelated or
irrelevant to the substantial equivalence evaluation;
``(III) shall review the labeling of the device to assess
the intended use of the device, and shall not evaluate issues
that do not present a major impact on the intended use as set
forth in the labeling;
``(IV) shall consider alternative approaches to evaluating
substantial equivalence in order to reduce the time, effort,
and cost of reaching proper resolution of the issue; and
``(V) shall use all reasonable mechanisms to lessen review
times and render regulatory decisions.''.
SEC. 5. AGENCY DOCUMENTATION AND REVIEW OF SIGNIFICANT DECISIONS.
Chapter V of the Federal Food, Drug, and Cosmetic Act is amended by
inserting after section 517 (21 U.S.C. 360g) the following:
``SEC. 517A. AGENCY DOCUMENTATION AND REVIEW OF SIGNIFICANT DECISIONS
REGARDING DEVICES.
``(a) Documentation of Rationale for Significant Decisions.--
``(1) In general.--The Secretary shall completely document
the scientific and regulatory rationale for any significant
decision of the Center for Devices and Radiological Health
regarding submission or review of a report under section
510(k), an application under section 515, or an application for
an exemption under section 520(g), including documentation of
significant controversies or differences of opinion and their
resolution.
``(2) Provision of documentation.--Upon request, the
Secretary shall furnish such complete documentation to the
person who is seeking to submit, or who has submitted, such
report or application.
``(b) Appeal Rights and Procedures.--
``(1) Appeal to center director.--Any person may, within 30
days after a significant decision described in subsection
(a)(1), appeal such decision to the Director of the Center for
Devices and Radiological Health (in this subsection referred to
as the `Center Director').
``(2) Petition; procedures.--The Center Director--
``(A) may require that an appeal under paragraph
(1) be in writing and set forth the decision being
appealed and the grounds for the appeal; and
``(B) subject to paragraph (6), may provide for
such procedures as may be necessary with respect to
such an appeal.
``(3) Resolution by center director.--
``(A) Meeting.--The Center Director shall provide,
upon the request of any person bringing an appeal under
paragraph (1), for at least one meeting, to be held
within 45 days after the filing of the appeal, to
discuss the significant decision involved, the appeal
of such decision, and possible resolutions of the
appeal.
``(B) Final decision.--The Center Director shall
issue a final written decision resolving any appeal
under paragraph (1), including the grounds for such
decision, not later than 90 days after the filing of
the appeal.
``(4) Appeal to commissioner.--
``(A) In general.--Any person who files an appeal
under paragraph (1)--
``(i) within 30 days after receiving any
decision of the Center Director resolving the
appeal, may appeal such decision to the
Commissioner; or
``(ii) if the Center Director has not made
a decision resolving the appeal under paragraph
(1) within 90 days after the filing of such
appeal, may file directly with the Commissioner
an appeal of the significant decision subject
to such appeal under paragraph (1).
``(B) Final decision.--The Commissioner shall issue
a final written decision resolving any appeal under
subparagraph (A), including the grounds for such
decision, not later than 30 days after the filing of
such appeal under subparagraph (A).
``(5) Report.--The Commissioner shall issue a public report
on at least an annual basis that sets forth--
``(A) the number of appeals under paragraph (1) and
the disposition of those appeals;
``(B) for each appeal under paragraph (1), the
number of days taken to reach a final decision under
paragraph (3)(B);
``(C) the number of appeals to the Commissioner
under paragraph (4)(A), including the number of such
appeals under paragraph (4)(A)(ii), and the disposition
of those appeals; and
``(D) the number of appeals for which the
Commissioner does not issue a final decision within 30
days as required by paragraph (4)(B).
``(6) Authority of secretary to establish appeal procedures
and timelines.--
``(A) Establishment.--Subject to subparagraph (B),
the Secretary may, by regulation or guidance, establish
appeal procedures or timelines applicable to appeals
under paragraph (1) or (4).
``(B) Limitation.--No procedure or timeline
established under subparagraph (A) may alter any
requirement or extend or delay any timeline specified
in any of paragraphs (1) through (5).''.
SEC. 6. TRANSPARENCY IN CLEARANCE PROCESS.
(a) Publication of Detailed Decision Summaries.--Section 520(h) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(h)) is amended
by adding at the end the following:
``(5) Subject to subsection (c) and section 301(j), the Secretary
shall regularly publish detailed decision summaries for each clearance
of a device under section 510(k).''.
(b) Application.--The requirement of section 520(h)(5) of the
Federal Food, Drug, and Cosmetic Act, as added by subsection (a),
applies only with respect to clearance of a device occurring after the
date of the enactment of this Act.
<all>