Rare Disease Innovation Act

Bill: 114-s-2188
Sponsor: full_name: Sen. Gardner, Cory [R-CO]
Introduced: 2015-10-21
Policy area: Health
Subjects: Administrative law and regulatory procedures

Congressional oversight

Department of Health and Human Services

Drug safety, medical device, and laboratory regulation

Health technology, devices, supplies
Latest action: action_date: 2015-10-21
text: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Summaries:
action_date: 2015-10-21
action_desc: Introduced in Senate
text: <p><b>Rare Disease Innovation Act</b></p> <p>This bill amends the Federal Food, Drug, and Cosmetic Act to expand the humanitarian device exemption to authorize the Food and Drug Administration (FDA) to exempt from effectiveness requirements certain medical devices intended to benefit fewer than 8,000 individuals. Currently, the FDA may exempt devices intended to benefit fewer than 4,000 individuals.</p> <p>Within 18 months of enactment of this Act, the FDA must define &ldquo;probable benefit&rdquo; for these devices.</p> <p>The FDA must report every five years on the effect of this expansion of the humanitarian device exception.</p>

tv_txt: II 114th CONGRESS 1st Session S. 2188 IN THE SENATE OF THE UNITED STATES October 21, 2015 Mr. Gardner (for himself and Mr. Donnelly ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To amend the Federal Food, Drug, and Cosmetic Act with respect to the humanitarian device exemption.

1. Short title This Act may be cited as the Rare Disease Innovation Act . 2. Humanitarian device exemption application (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 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Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall publish a draft guidance document that defines the criteria for establishing probable benefit as that term is used in section 520(m)(2)(C) of the Federal Food, Drug, and Cosmetic Act (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) ). (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).