FDA’s new GenAi draft framework: Risk assessments and extended responsibility

By Laura DiAngelo, MPH

FDA is beginning to outline how it could approach oversight of generative AI-enabled medical devices. A new discussion paper explores potential frameworks for assessing risk, evaluating performance and monitoring products after they reach the market — while leaving significant questions open for stakeholder feedback.

Though the paper is not a policy proposal, it offers an early look at how FDA thinking on GenAI regulation may be taking shape.

This AgencyIQ analysis examines the regulatory signals behind the discussion paper, where FDA may rely on existing pathways and the questions developers should be watching as the agency considers what comes next.

Fill out the form to read the full analysis.