FDA Publishes Final Order on AI CAD Petition

The FDA published a final order Sept. 17 denying a petition that sought to partially exempt certain AI-enabled radiology computer-aided detection, diagnosis and triage devices from 510(k) premarket notification requirements.

The petitioner proposed allowing the devices to bypass parts of the FDA premarket review process if developers met additional conditions. The criteria included post-market monitoring, increased transparency and developer experience in getting similar devices to market via FDA’s conventional pathways.

ACR^® filed comments in February outlining radiologists’ concerns and providing recommended enhancements to monitoring, transparency and regulatory visibility if the FDA were to move forward despite those concerns. After reviewing public comments, the agency formally denied the petition in April. This week’s formal publication of the final order completes the FDA’s process.

To learn more about ACR’s AI initiatives, visit the ACR Data Science Institute^®. For questions about AI and digital health policy, contact Michael Peters, ACR Senior Director, Government Affairs.