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Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall publish a draft guidance document that defines the criteria for establishing probable benefit as that term is used in section 520(m)(2)(C) of the Federal Food, Drug, and Cosmetic Act (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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