The U.S. Food and Drug Administration (FDA) has published a discussion paper to engage medical device manufacturers and other stakeholders on issues related to the development, regulation, and use of advanced medical devices that incorporate generative artificial intelligence (AI) technology.
The discussion paper, titled “Considerations for the Regulation of Generative AI-Enabled Medical Devices,” addresses several topics, including:
- Considerations for the assessment of risk for generative AI-enabled medical devices;
- Considerations for premarket evaluation of such devices;
- Postmarket monitoring considerations of such devices.
The discussion paper also includes questions for those stakeholders who would like to share their perspective on the issues raised in the paper.
The paper was prepared by the FDA’s Digital Health Center of Excellence (DHCoE), which operates under the FDA’s Center for Devices and Radiological Health (CDRH.)
Read the FDA’s discussion paper on the generative AI-enabled medical devices.
Comments on the paper can be filed through October 19, 2026, on the federal Regulations.gov website (reference docket number FDA-2026-N-7874).
