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FDA Seeks Feedback on Regulating Generative AI-Enabled Medical Devices
The FDA’s Digital Health Center of Excellence (DHCoE), within the Center for Devices and Radiological Health (CDRH), has published a discussion paper, “Considerations for the Regulation of Generative AI-Enabled Medical Devices,” and is requesting feedback from device manufacturers, clinicians, researchers, and the public.
The paper explores how generative AI (GenAI) may introduce unique risks compared with traditional software and AI-enabled devices, and poses questions across four areas: risk assessment, premarket evaluation, postmarket monitoring, and other regulatory considerations for GenAI-enabled medical devices.
Note: This is a discussion paper for early input only — it is not draft or final guidance and does not propose policy changes. Feedback may be submitted under docket FDA-2026-N-7874 on Regulations.gov through October 19, 2026.
Read the discussion paper on FDA.govESL curates this page to help readers track relevant regulatory and industry developments. External links point to official sources; ESL is not the publisher of third-party content and does not provide legal or regulatory advice. Product and company names are trademarks of their respective owners.