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S 4349 117th Congress Senate Health

A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to notifications of emerging signals concerning devices.

Introduced: June 6, 2022 Introduced by: Marshall, Roger Republican · Kansas See on congress.gov
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This bill died when the 117th Congress ended
It never became law before the 117th Congress (2021–2022) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 Everywhere this bill has been 2 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Jun 6, 2022
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Jun 6, 2022
Introduced in Senate
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 Plain-English summary Congressional Research Service

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.

What's happening now June 6, 2022

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

 Related & companion bills 1
  • HR 7646 Related bill Emerging Signals Modernization Act of 2022
 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 1
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APA
U.S. Congress. (2026). S. 4349: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to notifications of emerging signals concerning devices.. 117th Congress. Open America. https://openamerica.io/bill/117-S-4349/
MLA
"S. 4349: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to notifications of emerging signals concerning devices.." 117th Congress, 2026, Open America, https://openamerica.io/bill/117-S-4349/.
Bluebook (legal)
S. 4349, 117th Cong. (2026), https://openamerica.io/bill/117-S-4349/.
Markdown link
[S. 4349: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to notifications of emerging signals concerning devices.](https://openamerica.io/bill/117-S-4349/)
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