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.| Action Date | Type | Text | Source |
|---|---|---|---|
| 2015-05-22 | Committee | Referred to the Subcommittee on Health. | House committee actions |
| 2015-05-19 | IntroReferral | Referred to the House Committee on Energy and Commerce. | House floor actions |
| 2015-05-19 | IntroReferral | Introduced in House | Library of Congress |