FDA gets 500+ comments on generative AI medical devices; rule split emerges
mattlungrenMD · x · 2026-11-05
The FDA received 500+ comments on its generative AI device paper. Industry group AdvaMed wants existing premarket rules plus risk-based postmarket monitoring, while Stanford's Dr. Nina Vasan calls for separate pass/fail tests for high-stakes misses like missed sepsis or suicide risk — a clear split between embedding AI in current frameworks and imposing hard thresholds for high-risk scenarios.
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