I 

114TH CONGRESS 

1ST SESSION H. R. 2425 

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

recognition of standards. 

IN THE HOUSE OF REPRESENTATIVES 

MAY 19, 2015 

Mr. SHIMKUS 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 the recognition of standards. 

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

3 SECTION 1. RECOGNITION OF STANDARDS. 

4 Section 514(c) of the Federal Food, Drug, and Cos5 metic Act (21 U.S.C. 360d(c)) is amended— 

6 (1) in paragraph (1), by inserting after sub7 paragraph (B) the following new subparagraphs: 

8 ‘‘(C)(i) Any person may submit a request 

9 for recognition under subparagraph (A) of all 

10 or part of an appropriate standard established 


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1 by a nationally or internationally recognized 

2 standard organization. 

3 ‘‘(ii) Not later than 60 days after the Sec4 retary receives such a request, the Secretary 

5 shall— 

6 ‘‘(I) make a determination to recog7 nize all, part, or none of the standard that 

8 is the subject of the request; and 

9 ‘‘(II) issue to the person who sub10 mitted such request a response in writing 

11 that states the Secretary’s rationale for 

12 that determination, including the scientific, 

13 technical, regulatory, or other basis for 

14 such determination; 

15 ‘‘(iii) The Secretary make a response 

16 issued under clause (ii)(II) publicly available, in 

17 such manner as the Secretary determines ap18 propriate. 

19 ‘‘(iv) The Secretary shall take such actions 

20 as may be necessary to implement all or part of 

21 a standard recognized under subclause (I), in 

22 accordance with subparagraph (A). 

23 ‘‘(D) The Secretary shall make publicly 

24 available, in such manner as the Secretary de25 termines appropriate, the rationale for recogniVerDate Sep 11 2014 02:19 May 27, 2015 Jkt 049200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H2425.IH H2425

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1 tion under subparagraph (A) of part of a stand2 ard, including the scientific, technical, regu3 latory, or other basis for such recognition.’’; 

4 and 

5 (2) by adding at the end the following new 

6 paragraphs: 

7 ‘‘(4) TRAINING ON USE OF STANDARDS.—The 

8 Secretary shall provide to all employees of the Food 

9 and Drug Administration who review premarket sub10 missions for devices periodic training on the concept 

11 and use of recognized standards for purposes of 

12 meeting a premarket submission requirement or 

13 other applicable requirement under this Act, includ14 ing standards relevant to an employee’s area of de15 vice review. 

16 ‘‘(5) GUIDANCE.— 

17 ‘‘(A) DRAFT GUIDANCE.—The Secretary 

18 shall publish guidance identifying the principles 

19 for recognizing standards under this section. In 

20 publishing such guidance, the Secretary shall 

21 consider the experience with, and reliance on, a 

22 standard by other Federal regulatory authori23 ties and the device industry, and whether rec24 ognition of a standard will promote harmoniVerDate Sep 11 2014 02:19 May 27, 2015 Jkt 049200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H2425.IH H2425

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1 zation among regulatory authorities in the regu2 lation of devices. 

3 ‘‘(B) TIMING.—The Secretary shall pub4 lish— 

5 ‘‘(i) draft guidance under subpara6 graph (A) not later than 12 months after 

7 the date of the enactment of the 21st Cen8 tury Cures Act; and 

9 ‘‘(ii) final guidance not later than 12 

10 months of the close of the public comment 

11 period for the draft guidance under clause 

12 (i).’’. 

Æ 


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