AI in Medicine News ・ ⚖️ Device approvals and regulation

AdvaMed Encourages Risk-Based FDA Approach to Generative AI Medical Devices

AdvaMed® - Advanced Medical Technology Association® · 10/27 19:01 UTC

AdvaMed encouraged the U.S. Food and Drug Administration to build on its existing regulatory framework for generative AI-enabled medical devices rather than create new frameworks. The comments respond to an FDA discussion paper (Docket No. FDA-2026-N-7874) seeking early input on assessing risks and evaluating such devices before marketing and in post-market monitoring.

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