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 accredited to perform certain reviews or inspections. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘FDA Renewing Effi5 ciency From Outside Reviewer Management Act of 2011’’. 


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1 SEC. 2. PERSONS ACCREDITED TO REVIEW REPORTS 

2 UNDER 510(k) AND MAKE RECOMMENDA3 TIONS FOR INITIAL CLASSIFICATION. 

4 (a) TIME PERIOD FOR REVIEW OF RECOMMENDA5 TIONS OF ACCREDITED PERSONS.—Section 523(a) of the 

6 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

7 360m(a)) is amended— 

8 (1) in paragraph (1), by striking ‘‘reviewing re9 ports’’ and inserting ‘‘reviewing and making rec10 ommendations to the Secretary regarding reports’’; 

11 and 

12 (2) in paragraph (2), by amending subpara13 graph (B) to read as follows: 

14 ‘‘(B) TIME PERIOD FOR REVIEW.—Not 

15 later than 30 days after the date on which the 

16 Secretary is notified under subparagraph (A) by 

17 an accredited person with respect to a rec18 ommendation regarding a report submitted 

19 under section 510(k) or an initial classification 

20 of a device, the Secretary shall make a deter21 mination with respect to the recommendation. 

22 If the Secretary fails to make such a determina23 tion by the end of such 30-day period, the rec24 ommendation is deemed to be accepted by the 

25 Secretary.’’. 


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1 (b) ACCESS TO DEVICE INFORMATION.—Paragraph 

2 (2) of section 523(a) of the Federal Food, Drug, and Cos3 metic Act (21 U.S.C. 360m(a)) is amended by adding at 

4 the end the following: 

5 ‘‘(D) ACCESS TO DEVICE INFORMATION.— 

6 Subject to section 301(j), for the purpose of 

7 providing accredited persons with additional in8 formation to review reports submitted under 

9 section 510(k) and make recommendations re10 garding the initial classification of devices, the 

11 Secretary shall regularly publish— 

12 ‘‘(i) detailed decision summaries for 

13 each clearance of a device under section 

14 510(k), classification of a device under sec15 tion 513, approval of an application for a 

16 device under section 515, or grant of an 

17 exemption for a device under section 

18 520(m), occurring after the date of the en19 actment of this subparagraph; and 

20 ‘‘(ii) total product life cycles informa21 tion for devices.’’. 

22 (c) TYPES OF DEVICES TO BE REVIEWED.—Para23 graph (3) of section 523(a) of the Federal Food, Drug, 

24 and Cosmetic Act (21 U.S.C. 360m(a)) is amended to read 

25 as follows: 


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1 ‘‘(3) CERTAIN DEVICES.— 

2 ‘‘(A) IN GENERAL.—An accredited person 

3 may be used to perform a review regarding any 

4 report submitted under section 510(k) except 

5 that an accredited person— 

6 ‘‘(i) may not be used to perform a re7 view of a class III device; and 

8 ‘‘(ii) may be used to perform a review 

9 of a class II device which is intended to be 

10 permanently implantable or life sustaining 

11 or supporting only if a notification is sub12 mitted under subparagraph (B). 

13 ‘‘(B) NOTIFICATION OF INTENT TO PER14 FORM A REVIEW.—Before performing a review 

15 of a report submitted under section 510(k) for 

16 a class II device which is intended to be perma17 nently implantable or life sustaining or sup18 porting, an accredited person shall submit to 

19 the Secretary a notification of the person’s in20 tent to perform the review. If the Secretary 

21 does not object within 60 days after receipt of 

22 such a notification, the Secretary is deemed to 

23 allow the accredited person to perform such re24 view. If the Secretary objects to performance of 

25 the review by the accredited person, the SecVerDate Mar 15 2010 00:10 Oct 15, 2011 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H3205.IH H3205

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1 retary shall specify in writing the basis for the 

2 objection, including any reasons why the ac3 credited person is not capable of performing the 

4 review in a manner which provides a reasonable 

5 assurance of the safety and effectiveness of the 

6 device for its intended purpose.’’. 

7 (d) ACCREDITATION.—Section 523(b) of the Federal 

8 Food, Drug, and Cosmetic Act (21 U.S.C. 360m(b)) is 

9 amended— 

10 (1) in paragraph (2)— 

11 (A) in the heading of subparagraph (C), by 

12 inserting ‘‘AND TRAINING’’ after ‘‘AUDITING’’; 

13 (B) in subparagraph (C)— 

14 (i) in clause (i), by striking ‘‘and’’ at 

15 the end; 

16 (ii) by redesignating clause (ii) as 

17 clause (iii); and 

18 (iii) by inserting after clause (i) the 

19 following: 

20 ‘‘(ii) provide for the initial training 

21 and periodic updating of training of such 

22 person; and’’; and 

23 (C) by adding at the end the following: 

24 ‘‘(E) PERIODIC REACCREDITATION.— 


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1 ‘‘(i) PERIOD.—Subject to suspension 

2 or withdrawal under subparagraph (B), 

3 any accreditation under this section shall 

4 be valid for a period of 3 years after its 

5 issuance. 

6 ‘‘(ii) RESPONSE TO REACCREDITATION

7 REQUEST.—Upon the submission of a re8 quest by an accredited person to be re9 accredited under this section, the Secretary 

10 shall approve or deny such request not 

11 later than 60 days after receipt of the re12 quest. 

13 ‘‘(iii) CRITERIA.—Not later than 120 

14 days after the date of the enactment of 

15 this subparagraph, the Secretary shall es16 tablish and publish in the Federal Register 

17 criteria to reaccredit or deny reaccredita18 tion to persons under this section. The re19 accreditation of persons under this section 

20 shall specify the particular activities under 

21 subsection (a) for which such persons are 

22 accredited.’’; 

23 (2) in paragraph (3)— 

24 (A) in subparagraph (A), by inserting ‘‘a 

25 sole practitioner or’’ after ‘‘may not be’’; 


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1 (B) in subparagraph (B), by striking 

2 ‘‘such a manufacturer, supplier, or vendor’’ and 

3 inserting ‘‘a manufacturer, supplier, or vendor 

4 of devices of the type for which such person is 

5 accredited’’; and 

6 (C) in subparagraph (D), by striking ‘‘de7 vices’’ and inserting ‘‘devices of the type for 

8 which such person is accredited’’; 

9 (3) by striking paragraph (4) (relating to selec10 tion of accredited persons); and 

11 (4) by redesignating paragraph (5) as para12 graph (4). 

13 (e) DURATION OF AUTHORITY.—Section 523(c) of 

14 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

15 360m(c)) is amended by striking ‘‘October 1, 2012’’ and 

16 inserting ‘‘October 1, 2017’’. 

17 (f) REPORT.—Section 523(d) of the Federal Food, 

18 Drug, and Cosmetic Act (21 U.S.C. 360m(d)) is amended 

19 by striking ‘‘January 10, 2007’’ and inserting ‘‘January 

20 15, 2015’’. 

21 SEC. 3. PERSONS ACCREDITED TO CONDUCT INSPECTIONS. 

22 Section 704(g)(11) of the Federal Food, Drug, and 

23 Cosmetic Act (21 U.S.C. 374(g)(11)) is amended by strik24 ing ‘‘October 1, 2012’’ and inserting ‘‘October 1, 2017’’. 

Æ 


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