II 

112TH CONGRESS 

1ST SESSION S. 1700 

To amend the Federal Food, Drug, and Cosmetic Act with respect to device 

review determinations and conflicts of interest, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

OCTOBER 13, 2011 

Ms. KLOBUCHAR (for herself, Mr. BURR, and Mr. BENNET) introduced the 

following bill; which was read twice and referred to the Committee on 

Health, Education, Labor, and Pensions 

A BILL 

To amend the Federal Food, Drug, and Cosmetic Act with 

respect to device review determinations and conflicts of 

interest, and for other purposes. 

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 ‘‘Medical Device Regu5 latory Improvement Act’’. 

6 SEC. 2. CLARIFICATION OF LEAST BURDENSOME. 

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

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

9 360c(a)(3)(D)) is amended— 


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

2 and 

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

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

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

6 irrelevant to a demonstration of reasonable assur7 ance of device safety and effectiveness; 

8 ‘‘(II) shall consider alternative approaches to 

9 evaluating device safety and effectiveness in order to 

10 reduce the time, effort, and cost of reaching proper 

11 resolution of the issue; 

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

13 lessen review times and render regulatory decisions; 

14 ‘‘(IV) shall determine whether pre-clinical data, 

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

16 meet the statutory threshold for approval; and 

17 ‘‘(V) if clinical data are needed, shall utilize, 

18 whenever practicable, alternatives to randomized, 

19 controlled clinical trials, such as the use of surrogate 

20 endpoints.’’. 

21 (b) SUBSTANTIAL EQUIVALENCE DETERMINA22 TION.—Section 513(i)(1)(D) of the Federal Food, Drug, 

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

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

25 ‘‘(D)(i) Whenever’’; and 


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

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

3 ‘‘(I) shall focus on whether the device has the 

4 same intended use as the predicate device and is as 

5 safe and effective as a legally marketed device; 

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

7 unrelated or irrelevant to the substantial equivalence 

8 evaluation; 

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

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

11 evaluate issues that do not present a major impact 

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

13 ‘‘(IV) shall consider alternative approaches to 

14 evaluating substantial equivalence in order to reduce 

15 the time, effort, and cost of reaching proper resolu16 tion of the issue; and 

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

18 lessen review times and render regulatory deci19 sions.’’. 

20 SEC. 3. CONFLICTS OF INTEREST. 

21 Section 712 of the Federal Food, Drug, and Cosmetic 

22 Act (21 U.S.C. 379d–1) is amended to read as follows: 

23 ‘‘SEC. 712. CONFLICTS OF INTEREST. 

24 ‘‘Except as otherwise provided in this Act, each advi25 sory committee under the Federal Advisory Committee 


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1 Act that provides advice or recommendations to the Sec2 retary regarding activities of the Food and Drug Adminis3 tration is subject to the provisions in such Act and the 

4 members of each such committee are subject to the provi5 sions regarding Federal employees and special Govern6 ment employees, as applicable, in title I of the Ethics in 

7 Government Act of 1978 and section 208 of title 18, 

8 United States Code.’’. 

9 SEC. 4. MANAGEMENT AND INNOVATION REVIEW. 

10 (a) IN GENERAL.—Not later than 60 days after the 

11 date of enactment of this Act, the Secretary of Health and 

12 Human Services (referred to in this section as the ‘‘Sec13 retary’’) shall enter into a contract with an eligible entity 

14 to carry out the activities described in subsection (c). 

15 (b) ELIGIBLE ENTITY.—To be eligible to enter into 

16 a contract with the Secretary under subsection (a), an en17 tity shall— 

18 (1) be an entity with experience in evaluating 

19 the management and operating structure of large or20 ganizations; and 

21 (2) submit to the Secretary an application at 

22 such time, in such manner, and containing such in23 formation as the Secretary may require. 

24 (c) ACTIVITIES.—The entity with which the Secretary 

25 enters into the contract under subsection (a) shall, pursuVerDate Mar 15 2010 00:08 Oct 14, 2011 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S1700.IS S1700

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1 ant to such contract, conduct an extensive review of the 

2 management and regulatory processes at the Center for 

3 Devices and Radiological Health of the Food and Drug 

4 Administration to ensure any actions carried out by such 

5 Center take into consideration the potential impacts on in6 novation with respect to medical devices and other prod7 ucts regulated by such Center. 

8 (d) REPORT.—Not later than 1 year after the date 

9 that the Secretary enters into the contract with the eligible 

10 entity under subsection (a), such entity shall submit to 

11 Congress and the Secretary a report that describes the 

12 findings and recommendations of such entity based on the 

13 review conducted under subsection (c). 

14 (e) FUNDING.—To carry out this section, the Sec15 retary shall use funds otherwise available for the operation 

16 of the Office of the Secretary. 

Æ 


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