Bill > S2188

Introduced Session

Rare Disease Innovation Act 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. Within 18 months of enactment of this Act, the FDA must define "probable benefit" for these devices. The FDA must report every five years on the effect of this expansion of the humanitarian device exception.

Committee Categories

Cory Gardner (R)*,  Joe Donnelly (D), 

Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (on 10/21/2015)

Official Document