ACR Recommends Enhancements to FDA Draft AI Guidance

The American College of Radiology® (ACR®) provided comments to the U.S. Food and Drug Administration (FDA) regarding the agency’s draft guidance to address risk management approaches throughout the lifecycle of AI-enabled medical devices, including radiology AI. The document discusses information that manufacturers should share with FDA reviewers and other relevant stakeholders, including physicians and practices, to help them evaluate and monitor AI tools’ safety and effectiveness.

ACR’s comment letter supported the advancement of safe, effective, and clinically useful AI innovation. The College recommended further specificity in product information provided by manufacturers and regulators regarding clinical end-user qualifications. For example, radiologist end-users of imaging AI tools help mitigate risk because they are qualified to interpret imaging examinations without AI assistance. ACR also recommended various enhancements to the guidance’s content on site-level validation, performance monitoring and AI types with novel oversight considerations.  

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.