FDA seeks public input on regulating generative AI in medical devices

FDA is seeking public comment through Oct. 19 on how to regulate generative AI in medical devices, including risk assessment, premarket evaluation, and postmarket safety monitoring. Radiologist Rick Abramson now leads the Digital Health Center of Excellence.

• The FDA's Digital Health Center of Excellence released a discussion paper outlining considerations for generative AI-enabled medical devices, but it is not draft or final guidance.
• The agency plans a risk-based approach accounting for a product's intended use and technological characteristics to enable timely access while protecting public health.
• Feedback is encouraged from physicians, device manufacturers, consumers, and researchers through Oct. 19.

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