To amend the Federal Food, Drug, and Cosmetic Act to notify the public about an emerging signal concerning a medical device in order to reduce or limit the number of patients exposed to a potential risk identified based on such emerging signal, and for other purposes.
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.
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