I 

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. 

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 ‘‘Premarket Predict5 ability Act of 2011’’. 


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1 SEC. 2. TRACKING AND REVIEW OF APPLICATIONS FOR IN2 VESTIGATIONAL DEVICE EXEMPTIONS. 

3 Section 520(g) of the Federal Food, Drug, and Cos4 metic Act (21 U.S.C. 360j(g)) is amended by adding at 

5 the end the following: 

6 ‘‘(8)(A) Upon the submission of an application for 

7 an exemption for a device under this subsection, the sub8 mission of a request to classify a device under section 513, 

9 or the submission of a report for a device under section 

10 510(k), whichever occurs first, the Secretary shall assign 

11 a tracking number to the device. 

12 ‘‘(B) The Secretary shall use such tracking number 

13 to record the following interactions between the Secretary 

14 and applicant with respect to the device: 

15 ‘‘(i) Submission or approval of an application 

16 for an exemption under this subsection. 

17 ‘‘(ii) Submission or clearance of a report under 

18 section 510(k). 

19 ‘‘(iii) Any meeting or meeting request, including 

20 in anticipation of the submission of such an applica21 tion or report. 

22 ‘‘(iv) Submission or approval of an application 

23 under section 515(c). 

24 ‘‘(v) Any formal or informal request by the Sec25 retary for additional information. 

26 ‘‘(vi) Any deficiency letter. 


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1 ‘‘(vii) Any response by the applicant to a re2 quest described in clause (v) or a deficiency letter. 

3 ‘‘(viii) Any written submission by the applicant 

4 to the Food and Drug Administration. 

5 ‘‘(ix) Any other matter, as determined appro6 priate by the Secretary. 

7 ‘‘(9) Upon the submission of an application for an 

8 exemption under this subsection for a device, the Sec9 retary shall assign, to review the application, a reviewer 

10 with prior review experience with that type of device or 

11 technology or other relevant expertise.’’. 

12 SEC. 3. OTHER RULES RELATING TO INVESTIGATIONAL DE13 VICE EXEMPTIONS. 

14 Section 520(g) of the Federal Food, Drug, and Cos15 metic Act (21 U.S.C. 360j(g)) is amended— 

16 (1) in paragraph (2)(A), by adding at the end 

17 the following: ‘‘Procedures and conditions pursuant 

18 to the preceding sentence shall require the Sec19 retary, in determining whether to grant such an ex20 emption, to evaluate whether the investigational 

21 study can be conducted ethically and with reasonable 

22 risk.’’; 

23 (2) in paragraph (2)(B)(ii), by striking ‘‘evalu24 ate the safety and effectiveness of the device’’ and 

25 inserting ‘‘evaluate whether the investigational study 


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1 is being conducted ethically and with reasonable 

2 risk’’; 

3 (3) in paragraph (4)(B), by adding at the end 

4 the following: ‘‘The Secretary may not disapprove an 

5 application because the investigation does not or 

6 may not meet any requirement, including a data re7 quirement, relating to the approval or clearance of 

8 a device because the Secretary believes that a dif9 ferent clinical testing design or plan could produce 

10 data more relevant to an approval or clearance deci11 sion.’’; 

12 (4) in paragraph (7)(A), by striking ‘‘(7)(A) In 

13 the case’’ and all that follows through the end para14 graph (7)(A) and inserting the following: 

15 ‘‘(7)(A)(i) In the case of a person intending to inves16 tigate the safety or effectiveness of a class II or a class 

17 III device, the Secretary shall ensure that the person has 

18 an opportunity, prior to submitting an application to the 

19 Secretary, to submit to the Secretary, for review, an inves20 tigational plan (including a clinical protocol). If the appli21 cant submits a written request for a meeting with the Sec22 retary regarding such review, the Secretary shall, not later 

23 than 30 days after receiving the request, meet with the 

24 applicant for the purpose of reaching agreement regarding 

25 the investigational plan (including a clinical protocol). The 


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1 written request shall include a detailed description of the 

2 device, a detailed description of the proposed conditions 

3 of use of the device, information (if available) regarding 

4 the expected performance of the device, and a proposed 

5 plan (including a clinical protocol) for determining— 

6 ‘‘(I) whether there is a reasonable assurance of 

7 safety and effectiveness; or 

8 ‘‘(II) whether the device is substantially equiva9 lent to or is at least as safe and effective as a legally 

10 marketed device that is not subject to approval re11 quirements under section 515. 

12 ‘‘(ii) In the case where the Secretary fails to meet 

13 the applicant not later than 30 days after receiving a re14 quest as described under clause (i), the proposed plan sub15 mitted in such request shall be deemed to be the agree16 ment reached between the Secretary and the applicant 

17 under subparagraph (B) and such agreement shall not be 

18 subject to change except as provided in subparagraph 

19 (B).’’; and 

20 (5) in paragraph (7)(B)(ii), by inserting ‘‘that 

21 has emerged since the date of the agreement and 

22 that is’’ after ‘‘substantial scientific issue’’. 


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1 SEC. 4. CLARIFICATION OF LEAST BURDENSOME STAND2 ARD. 

3 (a) PREMARKET APPROVAL.—Section 513(a)(3)(D) 

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

5 360c(a)(3)(D)) is amended— 

6 (1) by redesignating clause (iii) as clause (iv); 

7 and 

8 (2) by inserting after clause (ii) the following: 

9 ‘‘(iii) In carrying out clause (ii), the Secretary— 

10 ‘‘(I) shall not request information unrelated or 

11 irrelevant to a demonstration of reasonable assur12 ance of device effectiveness; 

13 ‘‘(II) shall consider alternative approaches to 

14 evaluating device effectiveness in order to reduce the 

15 time, effort, and cost of reaching proper resolution 

16 of the issue; 

17 ‘‘(III) shall use all reasonable mechanisms to 

18 lessen review times and render regulatory decisions; 

19 ‘‘(IV) shall consider whether pre-clinical data, 

20 such as well-designed bench and animal testing, can 

21 meet the statutory threshold for approval; and 

22 ‘‘(V) if clinical data are needed, shall consider 

23 alternatives to randomized, controlled clinical trials 

24 and the use of surrogate endpoints.’’. 


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1 (b) SUBSTANTIAL EQUIVALENCE DETERMINA2 TION.—Section 513(i)(1)(D) of the Federal Food, Drug, 

3 and Cosmetic Act (21 U.S.C. 360c(i)(1)(D)) is amended— 

4 (1) by striking ‘‘(D) Whenever’’ and inserting 

5 ‘‘(D)(i) Whenever’’; and 

6 (2) by adding at the end the following: 

7 ‘‘(ii) In carrying out clause (i), the Secretary— 

8 ‘‘(I) shall focus on whether there is a reason9 able assurance that the device is safe and effective 

10 for its intended use; 

11 ‘‘(II) shall not request or accept information 

12 unrelated or irrelevant to the substantial equivalence 

13 evaluation; 

14 ‘‘(III) shall review the labeling of the device to 

15 assess the intended use of the device, and shall not 

16 evaluate issues that do not present a major impact 

17 on the intended use as set forth in the labeling; 

18 ‘‘(IV) shall consider alternative approaches to 

19 evaluating substantial equivalence in order to reduce 

20 the time, effort, and cost of reaching proper resolu21 tion of the issue; and 

22 ‘‘(V) shall use all reasonable mechanisms to 

23 lessen review times and render regulatory deci24 sions.’’. 


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1 SEC. 5. AGENCY DOCUMENTATION AND REVIEW OF SIG2 NIFICANT DECISIONS. 

3 Chapter V of the Federal Food, Drug, and Cosmetic 

4 Act is amended by inserting after section 517 (21 U.S.C. 

5 360g) the following: 

6 ‘‘SEC. 517A. AGENCY DOCUMENTATION AND REVIEW OF 

7 SIGNIFICANT DECISIONS REGARDING DE8 VICES. 

9 ‘‘(a) DOCUMENTATION OF RATIONALE FOR SIGNIFI10 CANT DECISIONS.— 

11 ‘‘(1) IN GENERAL.—The Secretary shall com12 pletely document the scientific and regulatory ration13 ale for any significant decision of the Center for De14 vices and Radiological Health regarding submission 

15 or review of a report under section 510(k), an appli16 cation under section 515, or an application for an 

17 exemption under section 520(g), including docu18 mentation of significant controversies or differences 

19 of opinion and their resolution. 

20 ‘‘(2) PROVISION OF DOCUMENTATION.—Upon 

21 request, the Secretary shall furnish such complete 

22 documentation to the person who is seeking to sub23 mit, or who has submitted, such report or applica24 tion. 

25 ‘‘(b) APPEAL RIGHTS AND PROCEDURES.— 


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1 ‘‘(1) APPEAL TO CENTER DIRECTOR.—Any per2 son may, within 30 days after a significant decision 

3 described in subsection (a)(1), appeal such decision 

4 to the Director of the Center for Devices and Radio5 logical Health (in this subsection referred to as the 

6 ‘Center Director’). 

7 ‘‘(2) PETITION; PROCEDURES.—The Center Di8 rector— 

9 ‘‘(A) may require that an appeal under 

10 paragraph (1) be in writing and set forth the 

11 decision being appealed and the grounds for the 

12 appeal; and 

13 ‘‘(B) subject to paragraph (6), may pro14 vide for such procedures as may be necessary 

15 with respect to such an appeal. 

16 ‘‘(3) RESOLUTION BY CENTER DIRECTOR.— 

17 ‘‘(A) MEETING.—The Center Director 

18 shall provide, upon the request of any person 

19 bringing an appeal under paragraph (1), for at 

20 least one meeting, to be held within 45 days 

21 after the filing of the appeal, to discuss the sig22 nificant decision involved, the appeal of such 

23 decision, and possible resolutions of the appeal. 

24 ‘‘(B) FINAL DECISION.—The Center Direc25 tor shall issue a final written decision resolving 


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1 any appeal under paragraph (1), including the 

2 grounds for such decision, not later than 90 

3 days after the filing of the appeal. 

4 ‘‘(4) APPEAL TO COMMISSIONER.— 

5 ‘‘(A) IN GENERAL.—Any person who files 

6 an appeal under paragraph (1)— 

7 ‘‘(i) within 30 days after receiving any 

8 decision of the Center Director resolving 

9 the appeal, may appeal such decision to 

10 the Commissioner; or 

11 ‘‘(ii) if the Center Director has not 

12 made a decision resolving the appeal under 

13 paragraph (1) within 90 days after the fil14 ing of such appeal, may file directly with 

15 the Commissioner an appeal of the signifi16 cant decision subject to such appeal under 

17 paragraph (1). 

18 ‘‘(B) FINAL DECISION.—The Commis19 sioner shall issue a final written decision resolv20 ing any appeal under subparagraph (A), includ21 ing the grounds for such decision, not later 

22 than 30 days after the filing of such appeal 

23 under subparagraph (A). 


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1 ‘‘(5) REPORT.—The Commissioner shall issue a 

2 public report on at least an annual basis that sets 

3 forth— 

4 ‘‘(A) the number of appeals under para5 graph (1) and the disposition of those appeals; 

6 ‘‘(B) for each appeal under paragraph (1), 

7 the number of days taken to reach a final deci8 sion under paragraph (3)(B); 

9 ‘‘(C) the number of appeals to the Com10 missioner under paragraph (4)(A), including 

11 the number of such appeals under paragraph 

12 (4)(A)(ii), and the disposition of those appeals; 

13 and 

14 ‘‘(D) the number of appeals for which the 

15 Commissioner does not issue a final decision 

16 within 30 days as required by paragraph 

17 (4)(B). 

18 ‘‘(6) AUTHORITY OF SECRETARY TO ESTABLISH

19 APPEAL PROCEDURES AND TIMELINES.— 

20 ‘‘(A) ESTABLISHMENT.—Subject to sub21 paragraph (B), the Secretary may, by regula22 tion or guidance, establish appeal procedures or 

23 timelines applicable to appeals under paragraph 

24 (1) or (4). 


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1 ‘‘(B) LIMITATION.—No procedure or 

2 timeline established under subparagraph (A) 

3 may alter any requirement or extend or delay 

4 any timeline specified in any of paragraphs (1) 

5 through (5).’’. 

6 SEC. 6. TRANSPARENCY IN CLEARANCE PROCESS. 

7 (a) PUBLICATION OF DETAILED DECISION SUM8 MARIES.—Section 520(h) of the Federal Food, Drug, and 

9 Cosmetic Act (21 U.S.C. 360j(h)) is amended by adding 

10 at the end the following: 

11 ‘‘(5) Subject to subsection (c) and section 301(j), the 

12 Secretary shall regularly publish detailed decision sum13 maries for each clearance of a device under section 

14 510(k).’’. 

15 (b) APPLICATION.—The requirement of section 

16 520(h)(5) of the Federal Food, Drug, and Cosmetic Act, 

17 as added by subsection (a), applies only with respect to 

18 clearance of a device occurring after the date of the enact19 ment of this Act. 

Æ 


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