FDA Seeks Public Feedback to Inform Regulatory Approach for Generative AI-Enabled Medical Devices
The FDA has released a discussion paper outlining regulatory considerations for generative AI-enabled medical devices, including frameworks for risk assessment, premarket evaluation, and postmarket monitoring. The agency is inviting comments from manufacturers, clinicians, researchers, and the public to shape policy for clinical AI tools, with feedback due by October 19, 2026.
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