FDA Rejects Petition to Exempt AI Radiology Software From 510(k) Clearance

The Food and Drug Administration has denied a petition seeking to exempt radiology computer-aided detection, diagnosis and triage software from 510(k) premarket notification, in a final order effective September 17, 2026. The determination, published in the Federal Register of 17 September 2026 as FR Doc. 2026–19074, closes Docket No. FDA–2025–P–5560 and leaves manufacturers of AI imaging tools obliged to obtain clearance before marketing. The order amends the framework of 21 CFR Part 892, the regulation governing radiology devices.

The petition was filed under section 510(m)(2) of the Federal Food, Drug, and Cosmetic Act, as amended by section 3054 of the 21st Century Cures Act (Pub. L. 114–255), signed into law on December 13, 2016. That provision allows the agency to exempt a class II device from premarket notification on its own initiative or on petition, provided it first publishes a notice and opens a 60-calendar-day comment period, and then issues an order with its final determination within 120 days of that notice. If the agency fails to respond to a petition within 180 days, the petition is deemed granted.

What the petition sought

The request, received by the agency on October 22, 2025, came from Nancy Stade, J.D., of Rubrum Advising, LLC, of Bala Cynwyd, Pennsylvania, acting on behalf of Harrison.ai. It asked for a partial exemption covering four generic device types:

• Radiological computer-assisted diagnostic software for lesions suspicious of cancer, classified under §892.2060, product code POK (CADx).
• Medical image analyzer, classified under §892.2070, product code MYN (CADe).
• Radiological computer aided triage and notification software, classified under §892.2080, product codes QAS and QFM (CADt).
• Radiological computer-assisted detection and diagnosis software, classified under §892.2090.

How the review unfolded

The agency published notice of the petition in the Federal Register on December 29, 2025 (90 FR 60730) and invited public comment. The comment period closed on February 27, 2026. After reviewing the docket and its own assessment, the agency responded by letter dated April 1, 2026, denying the petition within the 180-day statutory window.

In reaching that conclusion, the agency said it weighed the four factors it generally applies to class II exemption requests, set out in the Federal Register of January 21, 1998 (63 FR 3142) and in its February 19, 1998 guidance, “Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff.” Those factors cover a device’s history of false or misleading claims, how well the characteristics needed for safe and effective performance are established, whether changes affecting safety would be readily detectable or materially increase risk, and whether changes could alter classification.

What the order changes

The agency determined that the information in the petition does not demonstrate that premarket notification is unnecessary to assure the safety and effectiveness of the devices covered by the proposed partial exemption. Manufacturers of the subject CAD and CADt devices must therefore continue to submit a 510(k) and receive FDA clearance before marketing, and must comply with all other applicable requirements under the Act.

The order also states that the action is of a type that does not normally have a significant effect on the human environment under 21 CFR 25.34(b), so no environmental assessment or impact statement is required. It notes that the information collections involved are already approved by the Office of Management and Budget, including premarket notification procedures under control number 0910–0120. The order is signed by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs; the contact for the matter is Gugandeep Kaur of the Center for Devices and Radiological Health.

The decision keeps the premarket gate in place for one of the fastest-growing categories of medical software, meaning developers of AI tools for cancer detection, image analysis and triage face the same clearance burden as before. The agency nonetheless said it remains committed to innovative and least burdensome approaches to regulating device software and digital health products, leaving the door open to future exemption proposals built on stronger evidence.

Source: Federal Register, 17 September 2026 (official reference: FR Doc. 2026–19074; Docket No. FDA–2025–P–5560).