FDA 就生成式 AI 医疗器材监管公开征询：明确讨论稿不等于指引

Considerations for the Regulation of Generative AI-Enabled Medical Devices: Discussion Paper and Request for Feedback

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The Digital Health Center of Excellence (DHCoE), within the FDA’s Center for Devices and Radiological Health (CDRH), is leading a discussion paper on “Considerations for the Regulation of Generative AI-Enabled Medical Devices.”

Download PDF (8.8 MB)About the Discussion PaperGenAI‑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 covers the following topics and includes questions for each topic:considerations for the assessment of risk for GenAI-enabled medical devices, considerations for premarket evaluation of GenAI-enabled medical devices, postmarket monitoring for GenAI-enabled medical devices, and other topics relevant to the regulation of GenAI-enabled medical devices.DHCoE is seeking feedback on these topics and the questions in the discussion paper. Interested parties who opt to provide feedback are not required to respond to every question contained within the discussion paper and may choose to address only those questions or combination of questions or topics that are relevant to their expertise, experience, or organizational capacity, and may provide partial responses, as appropriate.This paper is intended for discussion purposes only and does not represent draft or final guidance. This paper is not intended to propose or implement policy changes regarding how CDRH intends to regulate generative AI-enabled devices. This paper is not intended to communicate CDRH's proposed (or final) regulatory expectations, including its expectations for supporting evidence in future marketing submissions, but is instead meant to seek early input from groups and individuals outside the Agency and to advance a broader discussion among stakeholders on this topic. Finally, this paper is not intended to address whether the approaches discussed are within FDA’s existing legal authorities or whether new legal authorities would be necessary. Submitting Feedback on the Discussion PaperDHCoE 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.Submit Feedback

Content current as of:

08/18/2026

Regulated Product(s)

Medical Devices