FDA Seeks Public Feedback to Inform Regulatory Approach for Generative AI-Enabled Medical Devices
The U.S. Food and Drug Administration (FDA) has issued a discussion paper on considerations for the regulation of generative artificial intelligence (GenAI)-enabled medical devices, seeking feedback from interested parties on risk assessment, premarket evaluation, postmarket monitoring, and other topics relevant to the regulation of GenAI-enabled medical devices.
The Digital Health Center of Excellence (DHCoE), within the FDA’s Center for Devices and Radiological Health, is leading this discussion paper which supports FDA's Public Health Pillar on Innovation and Global Leadership.
GenAI‑enabled medical devices hold transformative promise for patient care and the broader health ecosystem. At the same time, these devices may introduce unique risks when compared to traditional software and AI-enabled medical devices.
This discussion paper is intended to engage stakeholders on the challenges associated with GenAI-enabled medical devices and ways to advance regulatory approaches for these devices. The paper supports DHCoE’s efforts to advance health care by fostering innovation of safe, effective, and high-quality digital health technologies.
Submitting Feedback
DHCoE encourages feedback from device manufacturers, clinicians, researchers, the public, and other interested parties, to be submitted under docket number FDA-2026-N-7874 on Regulations.gov by October 19, 2026.
Questions?
If you have questions about this communication, contact digitalhealth@fda.hhs.gov.
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