FDA seeks feedback on potential regulatory approaches for generative AI-enabled medical devices

The Food and Drug Administration is seeking public feedback on a discussion paper released today on potential regulatory approaches for generative artificial intelligence-enabled medical devices. The paper includes considerations for risk assessment, premarket evaluation, post-market monitoring and other areas. The agency intends to gather early stakeholder input and advance broader discussion on policy frameworks for generative AI. The FDA said comments must be submitted by Oct. 19.