Sec. 3052. HUMANITARIAN DEVICE EXEMPTION
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/statute-compilations/comps-13005/sec-3052A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
## SEC. 3052 HUMANITARIAN DEVICE EXEMPTION ###
(a)In general Section 520(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j) is amended— ####
(1)in paragraph
(1)by striking “fewer than 4,000” and inserting “not more than 8,000”; ####
(2)in paragraph (2)(A) by striking “fewer than 4,000” and inserting “not more than 8,000”; and ####
(3)in paragraph (6)(A)(ii), by striking “4,000” and inserting “8,000”. ###
(b)Guidance Document on Probable Benefit **[**[21 U.S.C. 360j note](/us/usc/t21/s360j)**]** Not later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall publish a draft guidance that defines the criteria for establishing “probable benefit” as that term is used in section 520(m)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)(2)(C)).
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Sec. 3052
HUMANITARIAN DEVICE EXEMPTION
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