S. 2188
Referred to CommitteeRare Disease Innovation Act
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Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
10/21/2015 • Senate
Summary
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.
Introduced in Senate • 10/21/2015
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Sponsor & Cosponsors (2)
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Sponsor
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Bill Journey
Originated in the Senate
Introduced
October 21, 2015
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Committee Review
Floor Debate
Passed Chamber
Other Chamber
President
Enacted into Law