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- S.4349
S.4349: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to notifications of emerging signals concerning devices.
About This Bill
- This bill was introduced in the 117th Congress
- This bill is primarily about health
- Introduced June 6, 2022
- Latest Major Action June 6, 2022
Bill Sponsor
Bill Cosponsor
Bill Version
- Introduced in Senate - June 6, 2022
Bill 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.
(Source: Library of Congress)
Bill Actions
| Date | Description |
|---|---|
| June 6, 2022 |
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
|
| June 6, 2022 |
Introduced in the Senate by Roger Marshall (R-Kan.) |