SEC. 5. AGENCY DOCUMENTATION AND REVIEW OF SIG-
NIFICANT 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 
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 their resolution. 
‘‘(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) APPEAL RIGHTS AND PROCEDURES.— 
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‘‘(1) APPEAL TO CENTER DIRECTOR.—Any per-
son 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 Radio-
logical Health (in this subsection referred to as the 
‘Center Director’). 
‘‘(2) PETITION; PROCEDURES.—The Center Di-
rector— 
‘‘(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 pro-
vide 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 sig-
nificant decision involved, the appeal of such 
decision, and possible resolutions of the appeal. 
‘‘(B) FINAL DECISION.—The Center Direc-
tor shall issue a final written decision resolving 
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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 fil-
ing of such appeal, may file directly with 
the Commissioner an appeal of the signifi-
cant decision subject to such appeal under 
paragraph (1). 
‘‘(B) FINAL
DECISION.—The Commis-
sioner shall issue a final written decision resolv-
ing any appeal under subparagraph (A), includ-
ing the grounds for such decision, not later 
than 30 days after the filing of such appeal 
under subparagraph (A). 
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‘‘(5) REPORT.—The Commissioner shall issue a 
public report on at least an annual basis that sets 
forth— 
‘‘(A) the number of appeals under para-
graph (1) and the disposition of those appeals; 
‘‘(B) for each appeal under paragraph (1), 
the number of days taken to reach a final deci-
sion under paragraph (3)(B); 
‘‘(C) the number of appeals to the Com-
missioner 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 sub-
paragraph (B), the Secretary may, by regula-
tion or guidance, establish appeal procedures or 
timelines applicable to appeals under paragraph 
(1) or (4). 
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‘‘(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 SUM-
MARIES.—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 sum-
maries 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 enact-
ment of this Act. 
Æ 
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