ACR Weighs In on FDA GenAI Device Oversight

ACR^® recently told the FDA that the safety and effectiveness of GenAI-enabled medical devices depend not only on the technology itself, but also on the clinicians, workflows, data sources, governance structures and monitoring systems in which the AI operates. This was in response to the agency's discussion paper regarding regulatory considerations for generative AI (GenAI)-enabled medical devices, including risk assessment, premarket evaluation, post-market monitoring, change management and other issues.

The College, with substantial input from the ACR Data Science Institute^®, urged FDA to adopt a risk-based approach focused on a device's clinical function, degree of autonomy, and potential effects on patient care, while crediting qualified end-user oversight if demonstrated. ACR also recommended that regulatory flexibility for continuous improvement should be paired with robust post-market monitoring to identify clinically meaningful failures, performance drift, subgroup effects, and emerging risks. ACR encouraged FDA to work closely with the radiology community and other medical specialties as the agency develops future guidance and other policy initiatives.

More information about ACR’s AI initiatives is on the ACR Data Science Institute webpage. For questions regarding digital health and AI policy, contact Michael Peters, ACR Senior Director, Government Affairs.