149 
in accordance with clause (iii), the Sec-
retary shall— 
‘‘(I) conduct a retrospective anal-
ysis of such guidance document to en-
sure it is not outmoded, ineffective, 
insufficient, or excessively burden-
some; and 
‘‘(II) based on such analysis, 
modify, streamline, expand, or repeal 
the guidance document in accordance 
with what has been learned. 
‘‘(D) With respect to devices, a notice to 
industry guidance letter, a notice to industry 
advisory letter, and any similar notice that sets 
forth initial interpretations of a statute or regu-
lation or sets forth changes in interpretation or 
policy shall be treated as a guidance document 
for purposes of subparagraph (C). 
‘‘(E) The following shall not be treated as 
a guidance document for purposes of subpara-
graph (C): 
‘‘(i) Any document that does not set 
forth an initial interpretation or a reinter-
pretation of a statute or regulation. 
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‘‘(ii) Any document that sets forth or 
changes a policy relating to internal proce-
dures of the Food and Drug Administra-
tion. 
‘‘(iii) Agency reports, general informa-
tion documents provided to consumers or 
health professionals, speeches, journal arti-
cles and editorials, media interviews, press 
materials, warning letters, memoranda of 
understanding, or communications directed 
to individual persons or firms.’’. 
SEC. 602. CONFLICTS OF INTEREST. 
(a) IN GENERAL.—Section 712 (21 U.S.C. 379d–1) 
is amended— 
(1) by striking subsections (b) and (c) and in-
serting the following subsections: 
‘‘(b) RECRUITMENT FOR ADVISORY COMMITTEES.— 
‘‘(1) IN GENERAL.—The Secretary shall— 
‘‘(A) develop and implement strategies on 
effective outreach to potential members of advi-
sory committees at universities, colleges, other 
academic research centers, professional and 
medical societies, and patient and consumer 
groups; 
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‘‘(B) seek input from professional medical 
and scientific societies to determine the most ef-
fective informational and recruitment activities; 
‘‘(C) at least every 180 days, request refer-
rals for potential members of advisory commit-
tees from a variety of stakeholders, including— 
‘‘(i) 
product 
developers, 
patient 
groups, and disease advocacy organiza-
tions; and 
‘‘(ii) relevant— 
‘‘(I) professional societies; 
‘‘(II) medical societies; 
‘‘(III) 
academic 
organizations; 
and 
‘‘(IV) 
governmental 
organiza-
tions; and 
‘‘(D) in carrying out subparagraphs (A) 
and (B), take into account the levels of activity 
(including the numbers of annual meetings) and 
the numbers of vacancies of the advisory com-
mittees. 
‘‘(2) RECRUITMENT ACTIVITIES.—The recruit-
ment activities under paragraph (1) may include— 
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‘‘(A) advertising the process for becoming 
an advisory committee member at medical and 
scientific society conferences; 
‘‘(B) making widely available, including by 
using existing electronic communications chan-
nels, the contact information for the Food and 
Drug Administration point of contact regarding 
advisory committee nominations; and 
‘‘(C) developing a method through which 
an entity receiving funding from the National 
Institutes of Health, the Agency for Healthcare 
Research and Quality, the Centers for Disease 
Control and Prevention, or the Veterans Health 
Administration can identify a person whom the 
Food and Drug Administration can contact re-
garding the nomination of individuals to serve 
on advisory committees. 
‘‘(3) EXPERTISE.—In carrying out this sub-
section, the Secretary shall seek to ensure that the 
Secretary has access to the most current expert ad-
vice. 
‘‘(c) DISCLOSURE OF DETERMINATIONS AND CER-
TIFICATIONS.—Notwithstanding section 107(a)(2) of the 
Ethics in Government Act of 1978, the following shall 
apply: 
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‘‘(1) 15 OR MORE DAYS IN ADVANCE.—As soon 
as practicable, but (except as provided in paragraph 
(2)) not later than 15 days prior to a meeting of an 
advisory committee to which a written determination 
as referred to in section 208(b)(1) of title 18, 
United States Code, or a written certification as re-
ferred to in section 208(b)(3) of such title, applies, 
the Secretary shall disclose (other than information 
exempted from disclosure under section 552 or sec-
tion 552a of title 5, United States Code (popularly 
known as the Freedom of Information Act and the 
Privacy Act of 1974, respectively)) on the Internet 
Website of the Food and Drug Administration— 
‘‘(A) the type, nature, and magnitude of 
the financial interests of the advisory committee 
member to which such determination or certifi-
cation applies; and 
‘‘(B) the reasons of the Secretary for such 
determination or certification, including, as ap-
propriate, the public health interest in having 
the expertise of the member with respect to the 
particular matter before the advisory com-
mittee. 
‘‘(2) LESS THAN 30 DAYS IN ADVANCE.—In the 
case of a financial interest that becomes known to 
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the Secretary less than 30 days prior to a meeting 
of an advisory committee to which a written deter-
mination as referred to in section 208(b)(1) of title 
18, United States Code, or a written certification as 
referred to in section 208(b)(3) of such title applies, 
the Secretary shall disclose (other than information 
exempted from disclosure under section 552 or 552a 
of title 5, United States Code) on the Internet 
Website of the Food and Drug Administration, the 
information described in subparagraphs (A), (B), 
and (C) of paragraph (1) as soon as practicable 
after the Secretary makes such determination or cer-
tification, but in no case later than the date of such 
meeting.’’; 
(2) in subsection (d), by striking ‘‘subsection 
(c)(3)’’ and inserting ‘‘subsection (c)’’; 
(3) by amending subsection (e) to read as fol-
lows: 
‘‘(e) ANNUAL REPORT.— 
‘‘(1) IN GENERAL.—Not later than February 1 
of each year, the Secretary shall submit to the Com-
mittee on Appropriations and the Committee on 
Health, Education, Labor, and Pensions of the Sen-
ate, and the Committee on Appropriations and the 
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‘‘(C) with respect to such year, the number 
of members attending meetings for each advi-
sory committee; and 
‘‘(D) with respect to such year, the aggre-
gate number of disclosures required under sub-
section (d) and the percentage of individuals to 
whom such disclosures did not apply who served 
on such committee. 
‘‘(2) PUBLIC AVAILABILITY.—Not later than 30 
days after submitting any report under paragraph 
(1) to the committees specified in such paragraph, 
the Secretary shall make each such report available 
to the public.’’; and 
(4) in subsection (f), by striking ‘‘shall review 
guidance’’ and all that follows through the end of 
the subsection and inserting the following: ‘‘shall— 
‘‘(1) review guidance of the Food and Drug Ad-
ministration with respect to advisory committees re-
garding disclosure of conflicts of interest and the ap-
plication of section 208 of title 18, United States 
Code; and 
‘‘(2) update such guidance as necessary to en-
sure that the Food and Drug Administration re-
ceives appropriate access to needed scientific exper-
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tise, with due consideration of the requirements of 
such section 208.’’. 
(b) APPLICABILITY.—The amendments made by sub-
section (a) apply beginning on October 1, 2012. 
SEC. 603. ELECTRONIC SUBMISSION OF APPLICATIONS. 
Subchapter D of chapter VII (21 U.S.C. 379k et 
seq.) is amended by inserting after section 745 the fol-
lowing: 
‘‘SEC. 745A. ELECTRONIC FORMAT FOR SUBMISSIONS. 
‘‘(a) DRUGS AND BIOLOGICS.— 
‘‘(1) IN GENERAL.—Beginning no earlier than 
24 months after the issuance of a final guidance 
issued after public notice and opportunity for com-
ment, submissions under subsection (b), (i), or (j) of 
section 505 of this Act or subsection (a) or (k) of 
section 351 of the Public Health Service Act shall 
be submitted in such electronic format as specified 
by the Secretary in such guidance. 
‘‘(2) GUIDANCE CONTENTS.—In the guidance 
under paragraph (1), the Secretary may— 
‘‘(A) provide a timetable for establishment 
by the Secretary of further standards for elec-
tronic submission as required by such para-
graph; and 
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‘‘(B) set forth criteria for waivers of and 
exemptions from the requirements of this sub-
section. 
‘‘(3) EXCEPTION.—This subsection shall not 
apply to submissions described in section 561. 
‘‘(b) DEVICES.— 
‘‘(1) 
IN
GENERAL.—Beginning 
after 
the 
issuance of final guidance implementing this para-
graph, pre-submissions and submissions for devices 
under section 510(k), 513(f)(2)(A), 515(c), 515(d), 
515(f), 520(g), 520(m), or 564 of this Act or section 
351 of the Public Health Service Act, and any sup-
plements to such pre-submissions or submissions, 
shall include an electronic copy of such pre-submis-
sions or submissions. 
‘‘(2) GUIDANCE CONTENTS.—In the guidance 
under paragraph (1), the Secretary may— 
‘‘(A) provide standards for the electronic 
copy required under such paragraph; and 
‘‘(B) set forth criteria for waivers of and 
exemptions from the requirements of this sub-
section.’’. 
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SEC. 604. NOTIFICATION OF FDA INTENT TO REGULATE 
LABORATORY-DEVELOPED TESTS. 
The Food and Drug Administration may not issue 
any draft or final guidance on the regulation of laboratory- 
developed tests under the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 301 et seq.) without, at least 60 
days prior to such issuance— 
(1) notifying the Committee on Energy and 
Commerce of the House of Representatives and the 
Committee on Health, Education, Labor, and Pen-
sions of the Senate of the Administration’s intent to 
take such action; and 
(2) including in such notification the antici-
pated details of such action. 
TITLE VII—MEDICAL DEVICE 
REGULATORY IMPROVEMENTS 
Subtitle A—Premarket 
Predictability 
SEC. 701. INVESTIGATIONAL DEVICE EXEMPTIONS. 
Section 520(g) (21 U.S.C. 360j(g)) is amended— 
(1) in paragraph (2)(B)(ii), by inserting ‘‘safety 
or effectiveness’’ before ‘‘data obtained’’; and 
(2) in paragraph (4), by adding at the end the 
following: 
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‘‘(C) Consistent with paragraph (1), the Secretary 
shall not disapprove an application under this subsection 
because the Secretary determines that— 
‘‘(i) the investigation may not support a sub-
stantial equivalence or de novo classification deter-
mination or approval of the device; 
‘‘(ii) the investigation may not meet a require-
ment, including a data requirement, relating to the 
approval or clearance of a device; or 
‘‘(iii) an additional or different investigation 
may be necessary to support clearance or approval 
of the device.’’. 
SEC. 702. CLARIFICATION OF LEAST BURDENSOME STAND-
ARD. 
(a) PREMARKET APPROVAL.—Section 513(a)(3)(D) 
(21 U.S.C. 360c(a)(3)(D)) is amended— 
(1) by redesignating clause (iii) as clause (v); 
and 
(2) by inserting after clause (ii) the following: 
‘‘(iii) For purposes of clause (ii), the 
term ‘necessary’ means the minimum re-
quired information that would support a 
determination by the Secretary that an ap-
plication provides reasonable assurance of 
the effectiveness of the device. 
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‘‘(iv) Nothing in this subparagraph 
shall alter the criteria for evaluating an 
application for premarket approval of a de-
vice.’’. 
(b) PREMARKET NOTIFICATION UNDER SECTION 
510(k).—Section 513(i)(1)(D) (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) For purposes of clause (i), the term ‘necessary’ 
means the minimum required information that would sup-
port a determination of substantial equivalence between 
a new device and a predicate device. 
‘‘(iii) Nothing in this subparagraph shall alter the 
standard for determining substantial equivalence between 
a new device and a predicate device.’’. 
SEC. 703. AGENCY DOCUMENTATION AND REVIEW OF SIG-
NIFICANT DECISIONS. 
Chapter V is amended by inserting after section 517 
(21 U.S.C. 360g) the following: 
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‘‘SEC. 517A. AGENCY DOCUMENTATION AND REVIEW OF 
SIGNIFICANT 
DECISIONS 
REGARDING 
DE-
VICES. 
‘‘(a) DOCUMENTATION OF RATIONALE FOR SIGNIFI-
CANT DECISIONS.— 
‘‘(1) IN GENERAL.—The Secretary shall com-
pletely document the scientific and regulatory ration-
ale for any significant decision of the Center for De-
vices and Radiological Health regarding submission 
or review of a report under section 510(k), an appli-
cation under section 515, or an application for an 
exemption under section 520(g), including docu-
mentation 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 such complete 
documentation to the person who is seeking to sub-
mit, or who has submitted, such report or applica-
tion. 
‘‘(b) REVIEW OF SIGNIFICANT DECISIONS.— 
‘‘(1) REQUEST FOR SUPERVISORY REVIEW OF 
SIGNIFICANT DECISION.—Any person may request a 
supervisory review of the significant decision de-
scribed in subsection (a)(1). Such review may be 
conducted at the next supervisory level or higher 
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above the individual who made the significant deci-
sion. 
‘‘(2) SUBMISSION OF REQUEST.—A person re-
questing a supervisory review under paragraph (1) 
shall submit such request to the Secretary not later 
than 30 days after such decision and shall indicate 
in the request whether such person seeks an in-per-
son meeting or a teleconference review. 
‘‘(3) TIMEFRAME.— 
‘‘(A) IN GENERAL.—Except as provided in 
subparagraph (B), the Secretary shall schedule 
an in-person or teleconference review, if so re-
quested, not later than 30 days after such re-
quest is made. The Secretary shall issue a deci-
sion 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. 
‘‘(B) 
EXCEPTION.—Subparagraph 
(A) 
shall not apply in cases that are referred to ex-
perts outside of the Food and Drug Adminis-
tration.’’. 
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SEC. 704. TRANSPARENCY IN CLEARANCE PROCESS. 
(a) PUBLICATION
OF DETAILED DECISION SUM-
MARIES.—Section 520(h) (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 sum-
maries for each clearance of a device under section 510(k) 
requiring clinical data.’’. 
(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 enact-
ment of this Act. 
SEC. 705. DEVICE MODIFICATIONS REQUIRING PREMARKET 
NOTIFICATION PRIOR TO MARKETING. 
Section 510(n) (21 U.S.C. 360(n)) is amended by— 
(1) striking ‘‘(n) The Secretary’’ and inserting 
‘‘(n)(1) The Secretary’’; and 
(2) by adding at the end the following: 
‘‘(2)(A) Not later than 18 months after the en-
actment of this paragraph, the Secretary shall sub-
mit to the Committee on Energy and Commerce of 
the House of Representatives and the Committee on 
Health, Education, Labor, and Pensions of the Sen-
ate a report regarding when a premarket notification 
under subsection (k) should be submitted for a 
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modification or change to a legally marketed device. 
The report shall include the Secretary’s interpreta-
tion of the following terms: ‘could significantly affect 
the safety or effectiveness of the device’, ‘a signifi-
cant change or modification in design, material, 
chemical composition, energy source, or manufac-
turing process,’, and ‘major change or modification 
in the intended use of the device’. The report also 
shall discuss possible processes for industry to use to 
determine whether a new submission under sub-
section (k) is required and shall analyze how to le-
verage existing quality system requirements to re-
duce premarket burden, facilitate continual device 
improvement. and provide reasonable assurance of 
safety and effectiveness of modified devices. In de-
veloping such report, the Secretary shall consider the 
input of interested stakeholders. 
‘‘(B) The Secretary shall withdraw the Food 
and Drug Administration draft guidance entitled 
‘Guidance for Industry and FDA Staff—510(k) De-
vice Modifications: Deciding When to Submit a 
510(k) for a Change to an Existing Device’, dated 
July 27, 2011, and shall not use this draft guidance 
as part of, or for the basis of, any premarket review 
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or any compliance or enforcement decisions or ac-
tions. The Secretary shall not issue— 
‘‘(i) any draft guidance or proposed regula-
tion that addresses when to submit a premarket 
notification submission for changes and modi-
fications made to a manufacturer’s previously 
cleared device before the receipt by the Com-
mittee on Energy and Commerce of the House 
of Representatives and the Committee on 
Health, Education, Labor, and Pensions of the 
Senate of the report required in subparagraph 
(A); and 
‘‘(ii) any final guidance or regulation on 
that topic for one year after date of receipt of 
such report by the Committee on Energy and 
Commerce of the House of Representatives and 
the Committee on Health, Education, Labor, 
and Pensions of the Senate. 
‘‘(C) The Food and Drug Administration guid-
ance entitled ‘Deciding When to Submit a 510(k) for 
a Change to an Existing Device’, dated January 10, 
1997, shall be in effect until the subsequent issuance 
of guidance or promulgation, if appropriate, of a 
regulation described in subparagraph (B), and the 
Secretary shall interpret such guidance in a manner 
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