AI Reports · Stanford HAI · 2026-10-22 · Policy position
Response to FDA’s Request for Feedback on Considerations for the Regulation of GenAI-Enabled Medical Devices | Stanford HAI
Scholars from Stanford HAI and Stanford University's School of Medicine responded to the FDA's request for feedback on the regulation of generative AI-enabled medical devices. Their recommendations focus on operationalizing the two-axis risk assessment framework and ensuring the proposed competency-based approach to evaluation and monitoring can both maximize patient safety and support innovation. They call for requiring evidence that human oversight is an effective risk control, clarifying how the consequences axis is determined, strengthening benchmarking, establishing real-world prospective testing, and placing greater postmarket monitoring accountability on developers while equipping healthcare institutions to support continued monitoring.