United States · Bill · S
S. 4349 (117th)
A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to notifications of emerging signals concerning devices.
Introduced
6 June 2022
Last action
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Status
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Sponsors
—
Subjects
Discovery layer
Source updated
21 April 2025
Summary
This bill establishes certain requirements relating to the Food and Drug Administration's (FDA's) public notices on the potential new risks of approved medical devices (i.e., emerging signals), including with respect to the standards of evidence needed for such notices. The FDA must update its current guidance on emerging signals to align with the bill's requirements.
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Timeline
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Votes
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Versions
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Documents
3 official files
Introduced in Senate (text)
Introduced in Senate · EN · 6 June 2022
Introduced in Senate (PDF)
Introduced in Senate · EN · 6 June 2022
Introduced in Senate
summary · EN · 6 June 2022
Sponsors
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Related records
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Sources
PoliticalRepo is an index and interpretation layer, not the authoritative legal source.
- Official source: https://www.congress.gov/bill/117th-congress/senate-bill/4349
- Open data entity: https://api.congress.gov/v3/bill/117/s/4349