Sec. 2227. Humanitarian device exemption application

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Section 520(m) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360j ) is amended— in paragraph

(1)by striking fewer than 4,000 and inserting not more than 8,000 ; in paragraph (2)(A) by striking fewer than 4,000 and inserting not more than 8,000 ; and in paragraph (6)(A)(ii), by striking 4,000 and inserting 8,000 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Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall publish a draft guidance document that defines the criteria for establishing probable benefit as that term is used in section 520(m)(2)(C) of the Federal Food, Drug, and Cosmetic Act (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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U.S. Code

General provisions respecting control of devices intended for human use
§ 360j

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Sec. 2227

Humanitarian device exemption application

U.S.C.§ 360j

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