FDA discussion paper on generative AI devices asks how manufacturers should handle changes to third-party models. Comments close on 19 October
The FDA's Center for Devices and Radiological Health published a discussion paper on generative AI-enabled medical devices on 18 August, with feedback due by 19 October 2026. It discusses a possible two-axis risk framework and a competency-based approach to premarket evaluation, and asks about voluntary Foundation Model Device Master Files (MAFs) for third-party model developers. The FDA says the paper is not draft guidance.