A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to notifications of emerging signals concerning devices.

[AI summary unavailable — showing source text] 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.…