ACR Asks FDA to Prioritize Safety in AI CAD Petition Review

ACR^® recommended that the U.S. Food and Drug Administration ensure patient safety and device effectiveness as it considers a manufacturer’s petition to create optional, partial exemptions from the 510(k) clearance process for certain AI enabled computer-aided/assisted detection/diagnosis/triage (CAD) devices.

The petitioner requests that these radiology AI tools bypass FDA premarket notification procedures if developers meet added device-specific conditions, including post-market monitoring, enhanced user transparency and site distribution limitations.

ACR provided the agency with radiologists’ concerns and perspectives about the petition, and urged the agency to consider several modifications if the manufacturer’s proposal was to move forward, including:

• Narrowing which manufacturers and devices qualify.
• Ensuring end users have all appropriate clinical qualifications.
• Increasing device transparency before and after products reach the market.
• Enhancing FDA’s direct visibility into exempted devices and companies’ compliance.
• Requiring ongoing participation in third-party registries that monitor AI performance.
• Routinely reviewing the exemption pathway for safety/effectiveness concerns.

The FDA must follow a fast statutory review timeline and is expected to make a decision in the next few months.

For more information, contact Michael Peters, Senior Director of ACR Government Affairs.