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H.R. 7646

Emerging Signals Modernization Act of 2022

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.

Referred to the House Committee on Energy and Commerce.

Rep. Guthrie, Brett [R-KY-2](R-KY)Sponsor
1 cosponsor1 D
1cosponsors1committees3actions1related bills
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Emerging Signals Modernization Act of 2022 — Informed