ACR Presents to FDA on Oversight Considerations for GenAI Medical Devices

The American College of Radiology® (ACR®) presented Nov. 20-21 at the U.S. Food and Drug Administration (FDA) Digital Health Advisory Committee (DHAC) meeting “Total Product Lifecycle Considerations for Generative AI-Enabled Devices.” Bernardo Bizzo, MD, PhD, ACR Data Science Institute® Associate Chief Science Officer, represented the College at the meeting.

The meeting focused on novel oversight challenges and opportunities specific to FDA-regulated generative artificial intelligence (AI)-enabled devices. Per FDA’s definition, generative AI emulates the structure and characteristics of input data in order to generate derived synthetic content, such as images, videos, audio, text and other digital content; this typically is done by approximating the statistical distribution of the input data.

Dr. Bizzo provided overviews of the ACR Recognized Center for Healthcare-AI (ARCH-AI) quality assurance program, including the recently announced Assess-AI registry that provides radiology facilities with analytics on clinical AI performance over time as compared to national benchmarks. He discussed how ACR DSI programs and similar initiatives could be leveraged to help ensure the safety, effectiveness, and quality uses of generative AI-enabled devices.

For more information about ACR’s AI-related initiatives, visit the ACR DSI website. For questions about AI oversight and digital health policy, contact Michael Peters, ACR Senior Director, Government Affairs.