H.R. 2428
Referred to CommitteeTo amend the Federal Food, Drug, and Cosmetic Act with respect to humanitarian device exemption applications.
Latest Action
Referred to the Subcommittee on Health.
5/22/2015 • House
Summary
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.Introduced in House • 5/19/2015
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Bill Journey
Originated in the House
Introduced
May 19, 2015
Referred to the House Committee on Energy and Commerce.
Committee Review
Floor Debate
Passed Chamber
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Enacted into Law