April 11, 2025

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College of Radiology® (ACR®) provided comments to the U.S. Food and Drug Administration (FDA) regarding the agency’s draft guidance to address risk management approaches throughout the lifecycle of AI-enabled medical devices, including radiology AI.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.


Related ACR News

  • ACR Attends 2025 RUC Meetings

    ACR participated in the American Medical Association/Specialty Society RVS Update Committee meeting where they heard updates on the AMA Physician Practice Information Survey.

    Read more
  • NCI Releases FY 2027 Budget Proposal

    Anthony Letai, MD, PhD, became NCI Director Sept. 29, leading with a $7.2B budget and proposing $11.5B for FY 2027 to boost cancer research.

    Read more
  • Lead the Future of Alzheimer's Imaging

    Join ALZ-NET Imaging Network to access AI tools, boost Alzheimer’s imaging, and contribute data to shape FDA safety and clinical guidelines.

    Read more