H.R. 7646 · 117th Congress
Emerging Signals Modernization Act of 2022
- Stage
- In committee
- Sponsor
- Brett Guthrie
- Introduced
- 2022-05-03
- Latest action
- 2022-05-03 · Introduced in House
Summary
Emerging Signals Modernization Act of 2022
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.