Stanford HAI and Stanford Medicine respond to FDA on regulating GenAI-enabled medical devices
StanfordHAI · x · 2026-10-23
Scholars from Stanford HAI and Stanford Medicine submitted a formal response to the FDA's discussion paper on regulating generative AI-enabled medical devices. Key recommendations: require evidence that human oversight is an effective risk control for the tasks a device performs; clarify how the consequences axis of the two-axis risk framework is determined; strengthen premarket benchmarking to address construct validity and prevent metric optimization; and establish real-world prospective testing as a supplement or alternative to benchmarks, plus stronger postmarket oversight.
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