FDA releases discussion paper seeking input on regulation of generative AI medical devices

The U.S. Food and Drug Administration issued a discussion paper outlining considerations for regulating generative AI-enabled medical devices and asked stakeholders to provide feedback.

The paper requests comments on risk assessment, premarket evaluation, postmarket monitoring and other relevant topics.

The Digital Health Center of Excellence within the Center for Devices and Radiological Health is leading the effort, which supports the FDA’s public health pillar on innovation and global leadership.

Acting FDA Commissioner Kyle Diamantas said the agency is committed to advancing safe AI use in health care, and CDHR Director Michelle Tarver noted the need for a regulatory approach that keeps pace with rapid digital health innovation.