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College of Radiology® (ACR®) provided comments to the U.S. Food and Drug Administration (FDA) regarding the agency’s draft guidance to address risk management approaches throughout the lifecycle of AI-enabled medical devices, including radiology AI.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

  • Bill Introduced to Expand Access to Lung Cancer Screening

    The bill would enable healthcare organizations to purchase new mobile cancer screening units under a program within the HRSA, with an emphasis on lung cancer.

    Read more
  • ACR Urges HHS to Promote Annual Lung Cancer Screenings

    In a recent comment letter, the College presented updated data that highlights the life-saving potential of lung cancer screening.

    Read more
  • FDA Approves Alternative Standard Breast Density Reporting

    The Alternative Standard will allow the physician to provide an overall assessment of breast density with singular phrasing in reports of unilateral mammograms.

    Read more