ACR sends FDA a wish list for AI device 510(k) exemption petition

The American College of Radiology (ACR) has outlined several conditions it would like the U.S. Food and Drug Administration (FDA) to impose if it moves forward with a radiology AI manufacturer's petition to exempt certain AI-enabled computer-aided detection, diagnosis, and triage devices from the 510(k) clearance process.

The ACR's recommendations include the following:

• Narrowing which manufacturers and devices qualify for the exemption
• Ensuring end users have appropriate clinical qualifications
• Increasing device transparency before and after products reach the market
• Enhancing the 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 and effectiveness concerns

The FDA is considering allowing certain radiology AI tools to bypass FDA premarket notification procedures if developers meet added conditions, including post-market monitoring, enhanced user transparency, and site distribution limitations.

Facing a fast statutory review timeline, the FDA is expected to issue a decision within the next few months, according to the ACR.