Section 1 Short title
This Act may be cited as the “Rare Disease Innovation Act”.
Rare Disease Innovation Act
A BILL
To amend the Federal Food, Drug, and Cosmetic Act with respect to the humanitarian device exemption.
Sec. 2 Humanitarian device exemption application
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”.
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Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall publish a draft guidance document that defines the criteria for establishing “probable benefit” as that term is used in section 520(m)(2)(C) of the Federal Food, Drug, and Cosmetic Act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)).
Reports to Congress— Five years after the date of enactment of this Act and every 5 years thereafter, the Secretary of Health and Human Services shall submit to Congress a report on the effect of the amendments made by subsection (a).