The FDA’s GenAI proposal: evolving regulation for an evolved medtech era

The FDA has issued a discussion paper proposing a regulatory framework for generative AI in medical devices, with stakeholder feedback open until October 19, 2026. The proposal addresses oversight of GenAI-based medtech products, including questions around pre-market review, post-market monitoring, and software change management. Suppliers and device makers are invited to submit comments on the agency's evolving approach to AI regulation.