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FDA Releases Highly Anticipated Discussion Paper on Generative AI-Enabled Medical Devices

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  • FDA Releases Highly Anticipated Discussion Paper on Generative AI-Enabled Medical Devices

On August 18, 2026, FDA’s Center for Devices and Radiological Health (CDRH) released a discussion paper, Considerations for the Regulation of Generative AI-Enabled Medical Devices (the “GenAI Discussion Paper”). The GenAI Discussion Paper seeks public feedback on potential approaches to the evaluation and regulation of genAI-enabled medical devices. Stakeholder feedback is due by October 19, 2026. 

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