FDA Publishes Discussion Paper on Regulating Generative AI-Enabled Medical Devices
luisdans · x · 2026-08-26
The FDA's Digital Health Center of Excellence released a discussion paper on 'Considerations for the Regulation of Generative AI-Enabled Medical Devices.' It seeks stakeholder feedback on the unique risks and regulatory approaches for GenAI in medical devices, covering risk assessment, premarket evaluation, and postmarket surveillance.
Related event: FDA Issues Discussion Paper on Generative AI Medical Devices(2 posts)→
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