United States · Bill · HR
H.R. 2428 (114th)
To amend the Federal Food, Drug, and Cosmetic Act with respect to humanitarian device exemption applications.
Introduced
19 May 2015
Last action
—
Status
Referred to the Subcommittee on Health.
Sponsors
—
Subjects
Discovery layer
Source updated
3 January 2025
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.
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Documents
3 official files
Introduced in House (text)
Introduced in House (text)
Introduced in House · EN · 19 May 2015
Introduced in House (PDF)
Introduced in House · EN · 19 May 2015
Introduced in House
summary · EN · 19 May 2015
Sponsors
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Sources
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- Official source: https://www.congress.gov/bill/114th-congress/house-bill/2428
- Open data entity: https://api.congress.gov/v3/bill/114/hr/2428