High FDA

FDA Seeks Feedback on Potential Regulation of Generative AI Medical Devices

FDA issued a discussion paper seeking stakeholder input on regulatory approaches for GenAI-enabled medical devices due to concerns about unique risks like hallucinations and confabulations. The U.S.

Create a free account to read this complete brief and one more from every weekly edition. No card required.

Create a free account

Trust record

Verified · September 26, 2026