HUMANITARIAN DEVICE EXEMPTION.

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) [21 U.S.C. 360j note] Guidance Document on Probable Benefit.—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Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall publish a draft guidance that defines the criteria for establishing “probable benefit” as that term is used in section 520(m)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21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)).