To amend the Federal Food, Drug, and Cosmetic Act with respect to humanitarian device exemption applications.
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HR 2428 — To amend the Federal Food, Drug, and Cosmetic Act with respect to humanitarian device exemption applications.
Last action — Referred to the Subcommittee on Health.
No card. One bill, free forever — alerts when it moves.
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✓Introduced
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✓In Committee
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Died in session
This bill died with 114th Congress. It reached “In Committee” and never advanced before the session ended, so it can no longer move — a new version would have to be reintroduced in the current session.
This bill is no longer active — its legislative session has ended, so there is no live prognosis. It would have to be reintroduced in the current session to move again.
Summary
To amend the Federal Food, Drug, and Cosmetic Act with respect to humanitarian device exemption applications. 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.
Bill Text
We don't have the full text on file for this bill yet.
Read HR 2428 on the official United States source →Action History
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Referred to the Subcommittee on Health.
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Referred to the House Committee on Energy and Commerce.
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Introduced in House
Sponsors
- John Shimkus · Primary
Sponsorship breakdown
Export CSV (upgrade) →1 sponsors · 0 co-sponsors · 546 not signed on
Sponsors (1)
Co-sponsors (0)
None.
Not signed on (546)
546 members have not signed on to this bill.
Show all 546 →"Not signed on" means a member has not sponsored or co-sponsored this bill — it does not imply opposition. Members flagged Voted No have a recorded No vote on this bill.
Subjects
Frequently asked questions
- What does HR 2428 do?
- To amend the Federal Food, Drug, and Cosmetic Act with respect to humanitarian device exemption applications. 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.
- Who sponsors HR 2428?
- HR 2428 is sponsored by John Shimkus (R).
- What is the current status of HR 2428?
- This bill died with 114th Congress. It reached “In Committee” and never advanced before the session ended, so it can no longer move — a new version would have to be reintroduced in the current session.
- Where can I track HR 2428?
- Track HR 2428 free on One Click Politics — get push/email alerts when it moves.
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Last checked for changes about 9 hours ago · updated continuously
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