ACR Seeks Member Input on FDA GenAI Discussion Paper

The FDA published a discussion paper Aug. 18, asking stakeholders for feedback about agency oversight of generative AI-enabled medical devices. The paper is not a policy proposal, guidance or rule. Rather, it outlines concepts and asks targeted questions about risk assessment, premarket evaluation, post-market monitoring and other topics. Public comments on the paper will inform future related FDA regulatory policy initiatives.

The paper was informed by a November 2024 FDA Digital Health Advisory Committee meeting. At that meeting, ACR Data Science Institute® leaders presented radiology perspectives to the FDA and advisory committee members. 

ACR® experts are preparing a radiology response. College members who wish to provide feedback for possible inclusion in ACR’s comments, or would like more information or have questions may contact Michael Peters, ACR Senior Director, Government Affairs.