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. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. RECOGNITION OF STANDARDS. 
Section 514(c) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360d(c)) is amended— 
(1) in paragraph (1), by inserting after sub-
paragraph (B) the following new subparagraphs: 
‘‘(C)(i) Any person may submit a request 
for recognition under subparagraph (A) of all 
or part of an appropriate standard established 
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by a nationally or internationally recognized 
standard organization. 
‘‘(ii) Not later than 60 days after the Sec-
retary receives such a request, the Secretary 
shall— 
‘‘(I) make a determination to recog-
nize all, part, or none of the standard that 
is the subject of the request; and 
‘‘(II) issue to the person who sub-
mitted such request a response in writing 
that states the Secretary’s rationale for 
that determination, including the scientific, 
technical, regulatory, or other basis for 
such determination; 
‘‘(iii) The Secretary make a response 
issued under clause (ii)(II) publicly available, in 
such manner as the Secretary determines ap-
propriate. 
‘‘(iv) The Secretary shall take such actions 
as may be necessary to implement all or part of 
a standard recognized under subclause (I), in 
accordance with subparagraph (A). 
‘‘(D) The Secretary shall make publicly 
available, in such manner as the Secretary de-
termines appropriate, the rationale for recogni-
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tion under subparagraph (A) of part of a stand-
ard, including the scientific, technical, regu-
latory, or other basis for such recognition.’’; 
and 
(2) by adding at the end the following new 
paragraphs: 
‘‘(4) TRAINING ON USE OF STANDARDS.—The 
Secretary shall provide to all employees of the Food 
and Drug Administration who review premarket sub-
missions for devices periodic training on the concept 
and use of recognized standards for purposes of 
meeting a premarket submission requirement or 
other applicable requirement under this Act, includ-
ing standards relevant to an employee’s area of de-
vice review. 
‘‘(5) GUIDANCE.— 
‘‘(A) DRAFT
GUIDANCE.—The Secretary 
shall publish guidance identifying the principles 
for recognizing standards under this section. In 
publishing such guidance, the Secretary shall 
consider the experience with, and reliance on, a 
standard by other Federal regulatory authori-
ties and the device industry, and whether rec-
ognition of a standard will promote harmoni-
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zation among regulatory authorities in the regu-
lation of devices. 
‘‘(B) TIMING.—The Secretary shall pub-
lish— 
‘‘(i) draft guidance under subpara-
graph (A) not later than 12 months after 
the date of the enactment of the 21st Cen-
tury Cures Act; and 
‘‘(ii) final guidance not later than 12 
months of the close of the public comment 
period for the draft guidance under clause 
(i).’’. 
Æ 
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