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.
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
Plain-English 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.
What's happening now
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Committees of jurisdiction
1