The agency released a discussion paper to address the unique risks and potential of generative artificial intelligence in the healthcare ecosystem.
The Food and Drug Administration (FDA) Digital Health Center of Excellence released a discussion paper regarding the regulation of generative artificial intelligence (AI)-enabled medical devices. The document is intended to engage stakeholders on the challenges and risks associated with the technology to help advance future regulatory approaches.
Generative AI-enabled medical devices hold “transformative promise” for patient care and the broader health ecosystem, the Digital Health Center of Excellence says. However, the agency notes that these devices may introduce unique risks when compared to traditional software and other AI-enabled medical devices.
Gathering Stakeholder Feedback
The paper covers several topics and includes specific questions for each. The Digital Health Center of Excellence is seeking feedback from device manufacturers, clinicians, researchers, and the public to help the Center for Devices and Radiological Health advance its understanding of the technology. Interested parties are not required to respond to every question and may provide partial responses based on their expertise, experience, or organizational capacity.
The FDA emphasizes that this paper is for discussion purposes only and does not represent draft or final guidance. It is not intended to propose or implement policy changes regarding how the Center for Devices and Radiological Health regulates these devices. Furthermore, the paper does not communicate proposed regulatory expectations or requirements for supporting evidence in future marketing submissions.
The agency is seeking early input to advance a broader discussion among stakeholders. The paper also does not address whether the approaches discussed are within existing legal authorities or if new legal authorities would be necessary.
Submission Process
The Digital Health Center of Excellence is accepting comments under docket number FDA-2026-N-7874 on Regulations.gov. The agency encourages participation from across the healthcare technology management sector to ensure a variety of perspectives are considered.
The deadline for feedback is Oct 19, 2026.
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