II 

112TH CONGRESS 

2D SESSION S. 2067 

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

device regulation, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

FEBRUARY 2, 2012 

Mr. CASEY (for himself and Mr. MCCAIN) 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 medical device regulation, 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; TABLE OF CONTENTS. 

4 (a) SHORT TITLE.—This Act may be cited as the 

5 ‘‘Safe, Efficient, and Transparent Medical Device Ap6 proval Act’’ or the ‘‘SET Device Act’’. 

7 (b) TABLE OF CONTENTS.—The table of contents for 

8 this Act is as follows: 

Sec. 1. Short title; table of contents. 

Sec. 2. Findings. 

Sec. 3. Establishment of schedule and promulgation of regulation. 

Sec. 4. Modification of de novo application process. 


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1 SEC. 2. FINDINGS. 

2 Congress finds as follows: 

3 (1) Under the Safe Medical Devices Act of 

4 1990 (Public Law 101–629), Congress amended sec5 tion 515 of the Federal Food, Drug, and Cosmetic 

6 Act (21 U.S.C. 360e) to require the Food and Drug 

7 Administration to reclassify preamendment class III 

8 devices to a lower class or to require them to go 

9 through the premarket approval process. 

10 (2) The Food and Drug Administration has not 

11 yet complied with the mandate of Congress under 

12 such Act. 

13 (3) The de novo process, created by the Food 

14 and Drug Administration Modernization Act of 1997 

15 (Public Law 105–115), is an approval mechanism by 

16 which the Food and Drug Administration may 

17 down-classify, to class I or class II, devices that have 

18 no predicates and thus are designated class III, but 

19 are deemed to be of low to moderate risk. The proc20 ess avoids having novel, low- to moderate-risk de21 vices go through the premarket approval process. 

22 Under the current de novo process, the manufac23 turer must first make a submission under section 

24 510(k) of the Federal Food, Drug, and Cosmetic 

25 Act (21 U.S.C. 360), even if no known predicate de26 vice exists. A 2011 Institute of Medicine report 


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1 found that, between 2005 and 2009, review times 

2 for novel therapeutic devices through the de novo 

3 process nearly tripled. The report concluded that the 

4 current de novo process has not met its potential as 

5 an alternative regulatory pathway, and recommended 

6 the establishment of a modified de novo process. 

7 SEC. 3. ESTABLISHMENT OF SCHEDULE AND PROMULGA8 TION OF REGULATION. 

9 (a) ESTABLISHMENT OF SCHEDULE.—Not later than 

10 120 days after the date of enactment of this Act, the Sec11 retary of Health and Human Services (referred to in this 

12 section as the ‘‘Secretary’’), shall establish the schedule 

13 referred to in section 515(i)(3) of the Federal Food, Drug, 

14 and Cosmetic Act (21 U.S.C. 360e(i)(3)) for each device 

15 that the Secretary requires to remain in class III through 

16 a determination under section 515(i)(2) of such Act. 

17 (b) ACTION REGARDING CLASS II AND III.—Not 

18 later than 18 months after the date of enactment of this 

19 Act, the Secretary shall— 

20 (1) issue a final regulation under section 515(b) 

21 of the Federal Food, Drug, and Cosmetic Act (21 

22 U.S.C. 360e(b)) for each device that the Secretary 

23 requires to remain in class III through a determina24 tion under section 515(i)(2) of such Act; and 


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1 (2) establish the special controls required by 

2 section 513(a)(1)(B) of such Act (21 U.S.C. 

3 360c(a)(1)(B)) for each device that is classified into 

4 class II pursuant to a determination revising the 

5 classification of the device under section 515(i)(2) of 

6 such Act. 

7 SEC. 4. MODIFICATION OF DE NOVO APPLICATION PROC8 ESS. 

9 (a) IN GENERAL.—Section 513(f)(2) of the Federal 

10 Food, Drug, and Cosmetic Act (21 U.S.C. 360c(f)(2)) is 

11 amended— 

12 (1) by redesignating subparagraphs (B) and 

13 (C) as subparagraphs (C) and (D), respectively; 

14 (2) by amending subparagraph (A) to read as 

15 follows: 

16 ‘‘(A) In the case of a type of device that has not pre17 viously been classified under this Act, a person may do 

18 one of the following: 

19 ‘‘(i) Submit a report under section 510(k), and, 

20 if the device is classified into class III under para21 graph (1), such person may request, not later than 

22 30 days after receiving written notice of such a clas23 sification, the Secretary to classify the device under 

24 the criteria set forth in subparagraphs (A) through 

25 (C) of subsection (a)(1). The person may, in the reVerDate Mar 15 2010 22:36 Feb 03, 2012 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S2067.IS S2067

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1 quest, recommend to the Secretary a classification 

2 for the device. Any such request shall describe the 

3 device and provide detailed information and reasons 

4 for the recommended classification. 

5 ‘‘(ii) Submit a request for initial classification 

6 of the device under this subparagraph, if the person 

7 declares that there is no legally marketed device 

8 upon which to base a substantial equivalence deter9 mination as that term is defined in section 513(i). 

10 Subject to subparagraph (B), the Secretary shall 

11 classify the device under the criteria set forth in sub12 paragraphs (A) through (C) of subsection (a)(1). 

13 The person submitting the request for classification 

14 under this subparagraph may recommend to the 

15 Secretary a classification for the device and shall in16 clude in the request an initial draft proposal for ap17 plicable special controls, as described in subsection 

18 (a)(1)(B), that are necessary, in conjunction with 

19 general controls, to provide reasonable assurance of 

20 safety and effectiveness and a description of how the 

21 special controls provide such assurance.’’; 

22 (3) by inserting after subparagraph (A) the fol23 lowing: 

24 ‘‘(B) The Secretary may decline to undertake a clas25 sification request submitted under clause (2)(A)(ii) if the 


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1 Secretary identifies a legally marketed device that could 

2 provide a reasonable basis for review of substantial equiva3 lence under paragraph (1), or when the Secretary deter4 mines that the device submitted is not of low-moderate 

5 risk.’’; and 

6 (4) in subparagraph (C), as so redesignated— 

7 (A) in clause (i), by striking ‘‘Not later 

8 than 60 days after the date of the submission 

9 of the request under subparagraph (A),’’ and 

10 inserting ‘‘Not later than 90 days after the date 

11 of the submission of the request under subpara12 graph (A)(i) or 120 days after the date of the 

13 submission of the request under subparagraph 

14 (A)(ii),’’; and 

15 (B) in clause (ii), by inserting ‘‘or is classi16 fied in’’ after ‘‘remains in’’. 

17 (b) GAO REPORT.—Not later than 2 years after the 

18 date of enactment of this Act, the Comptroller General 

19 of the United States shall complete a study and submit 

20 to Congress a report on the effectiveness of the review 

21 pathway under section 513(f)(2)(A) of the Federal Food, 

22 Drug, and Cosmetic Act, as amended by this Act. 

23 (c) CONFORMING AMENDMENT.—Section 

24 513(f)(1)(B) of the Federal Food, Drug, and Cosmetic 


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1 Act (21 U.S.C. 360c(f)(1)(B)) is amended by inserting ‘‘a 

2 request under paragraph (2) or’’ after ‘‘response to’’. 

Æ 


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