Sec. 3053. RECOGNITION OF STANDARDS
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## SEC. 3053 RECOGNITION OF STANDARDS ###
(a)In general Section 514(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360d(c)) is amended— ####
(1)in paragraph (1), by inserting after subparagraph
(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 by a nationally or internationally recognized standard organization. > > > ###### “(ii) > > Not later than 60 calendar days after the Secretary receives such a request, the Secretary shall— > > > ###### “(I) > > make a determination to recognize all, part, or none of the standard that is the subject of the request; and > > > ###### “(II) > > issue to the person who submitted 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 shall make a response issued under clause (ii)(II) publicly available, in such a manner as the Secretary determines appropriate. > > > ###### “(iv) > > The Secretary shall take such actions as may be necessary to implement all or part of a standard recognized under clause (ii)(I), in accordance with subparagraph (A). > > > ##### “(D) > > The Secretary shall make publicly available, in such manner as the Secretary determines appropriate, the rationale for recognition under subparagraph
(A)of all, part, or none of a standard, including the scientific, technical, regulatory, or other basis for the decision regarding such recognition.” > ; and ####
(2)by adding at the end the following: > > #### “(4) > > The Secretary shall provide to all employees of the Food and Drug Administration who review premarket submissions 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, including standards relevant to an employee’s area of device review.” > . ###
(b)Guidance **[**[21 U.S.C. 360d note](/us/usc/t21/s360d)**]** The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall review and update, if necessary, previously published guidance and standard operating procedures identifying the principles for recognizing standards, and for withdrawing the recognition of standards, under section 514(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360d(c)), taking into account the experience with and reliance on a standard by foreign regulatory authorities and the device industry, and whether recognition of a standard will promote harmonization among regulatory authorities in the regulation of devices.
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Sec. 3053
RECOGNITION OF STANDARDS
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