Bill > HR2428

Introduced Session

To amend the Federal Food, Drug, and Cosmetic Act with respect to humanitarian device exemption applications. 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.

Committee Categories

John Shimkus (R)*, 

Referred to the Subcommittee on Health. (on 05/22/2015)

Official Document