United States · Bill · S
S. 2188 (114th)
Rare Disease Innovation Act
Introduced
21 October 2015
Last action
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Status
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Sponsors
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Subjects
Discovery layer
Source updated
12 August 2025
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.
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Documents
3 official files
Introduced in Senate (text)
Introduced in Senate · EN · 21 October 2015
Introduced in Senate (PDF)
Introduced in Senate · EN · 21 October 2015
Introduced in Senate
summary · EN · 21 October 2015
Sponsors
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Sources
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- Official source: https://www.congress.gov/bill/114th-congress/senate-bill/2188
- Open data entity: https://api.congress.gov/v3/bill/114/s/2188