I 
112TH CONGRESS 
1ST SESSION H. R. 3205 
To amend the Federal Food, Drug, and Cosmetic Act with respect to persons 
who, with respect to devices, are accredited to perform certain reviews 
or inspections. 
IN THE HOUSE OF REPRESENTATIVES 
OCTOBER 14, 2011 
Mr. PAULSEN (for himself, Mr. ALTMIRE, Mr. KINZINGER of Illinois, Mr. 
GUTHRIE, Mr. CASSIDY, Mr. SHIMKUS, Mrs. MCMORRIS RODGERS, Mrs. 
BLACKBURN, Mr. LATTA, Mr. KLINE, Mrs. BACHMANN, Mr. CRAVAACK, 
Mrs. BONO MACK, and Mr. BILBRAY) 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 with 
respect to persons who, with respect to devices, are ac-
credited to perform certain reviews or inspections. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘FDA Renewing Effi-
ciency From Outside Reviewer Management Act of 2011’’. 
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SEC. 2. PERSONS ACCREDITED TO REVIEW REPORTS 
UNDER 
510(k) 
AND 
MAKE 
RECOMMENDA-
TIONS FOR INITIAL CLASSIFICATION. 
(a) TIME PERIOD FOR REVIEW OF RECOMMENDA-
TIONS OF ACCREDITED PERSONS.—Section 523(a) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360m(a)) is amended— 
(1) in paragraph (1), by striking ‘‘reviewing re-
ports’’ and inserting ‘‘reviewing and making rec-
ommendations to the Secretary regarding reports’’; 
and 
(2) in paragraph (2), by amending subpara-
graph (B) to read as follows: 
‘‘(B) TIME
PERIOD
FOR
REVIEW.—Not 
later than 30 days after the date on which the 
Secretary is notified under subparagraph (A) by 
an accredited person with respect to a rec-
ommendation regarding a report submitted 
under section 510(k) or an initial classification 
of a device, the Secretary shall make a deter-
mination with respect to the recommendation. 
If the Secretary fails to make such a determina-
tion by the end of such 30-day period, the rec-
ommendation is deemed to be accepted by the 
Secretary.’’. 
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(b) ACCESS TO DEVICE INFORMATION.—Paragraph 
(2) of section 523(a) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360m(a)) is amended by adding at 
the end the following: 
‘‘(D) ACCESS TO DEVICE INFORMATION.— 
Subject to section 301(j), for the purpose of 
providing accredited persons with additional in-
formation to review reports submitted under 
section 510(k) and make recommendations re-
garding the initial classification of devices, the 
Secretary shall regularly publish— 
‘‘(i) detailed decision summaries for 
each clearance of a device under section 
510(k), classification of a device under sec-
tion 513, approval of an application for a 
device under section 515, or grant of an 
exemption for a device under section 
520(m), occurring after the date of the en-
actment of this subparagraph; and 
‘‘(ii) total product life cycles informa-
tion for devices.’’. 
(c) TYPES OF DEVICES TO BE REVIEWED.—Para-
graph (3) of section 523(a) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360m(a)) is amended to read 
as follows: 
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