FDA Seeks Public Feedback on Regulatory Approach for Generative AI-Enabled Medical Devices

The FDA is developing a regulatory approach for medical devices that use generative artificial intelligence (GenAI), with the agency seeking public input on how to evaluate their risks and performance.

The proposed framework would consider both a device’s clinical significance and level of autonomy, while a new “competency assessment” could combine non-clinical testing with clinical confirmation before approval. The FDA also is considering how to monitor these systems after deployment, including changes to underlying foundation models.

The discussion paper does not establish current regulatory requirements, but could help shape future guidance as GenAI becomes more integrated into medical devices. Read more National Law Review here.