FDA Order Keeps 510(k) Review for Radiology AI Detection and Triage Software

Makers of artificial intelligence software that detects, diagnoses or triages findings on medical images must keep obtaining FDA 510(k) clearance before marketing each device, under a final order published in the Federal Register on September 17. The order sets out the agency's final determination on a petition that sought a partial exemption from premarket notification for radiology computer-aided detection and diagnosis (CAD) and computer-aided triage and notification (CADt) devices.

"Manufacturers of the Subject CAD and CADt Devices must continue to submit and receive FDA clearance of a 510(k) submission before marketing their devices," the order states.

What the petition asked for

According to the order, FDA received the petition on October 22, 2025, from Rubrum Advising on behalf of Harrison.ai. It covered four generic device types: radiological computer-assisted diagnostic software for lesions suspicious of cancer (product code POK); medical image analyzers (MYN); radiological computer-aided triage and notification software (QAS and QFM); and radiological computer-assisted detection and diagnosis software (QBS and QDQ).

The petition proposed that a manufacturer that already held a 510(k) clearance under the relevant regulations could bring further devices to market without a new submission, provided it carried out what the petition called "a robust post-market plan, transparency, and training measures" and kept existing special controls, quality system, registration and listing requirements in force.

When FDA opened the petition for comment in December 2025, Discoveries in Health Policy summarized its central argument: that US radiology AI clearances typically cover only one or two findings per submission, while regulators in Europe, the UK and Asia-Pacific clear multi-finding systems, leaving US versions of some tools narrower than their counterparts abroad. Harrison.ai is an Australia-based imaging AI company, the blog noted.

Why FDA said no

The comment period closed on February 27, 2026. FDA said it weighed the docket comments and its own assessment of the four factors it uses to judge whether a class II device can be exempted, and concluded that the petition "does not demonstrate that premarket notification is not necessary to assure the safety and effectiveness" of the devices covered. The agency denied the petition by letter on April 1, 2026, within the 180-day deadline set by the Federal Food, Drug, and Cosmetic Act, and the statute also requires it to publish an order with its final determination.

Those factors, as listed in the order, include whether a device type has a significant history of false or misleading claims or inherent risks, whether the characteristics needed for safe and effective performance are well established, and whether changes that could affect safety and effectiveness would be readily detected by users before causing harm.

The order leaves the door open to other approaches. FDA wrote that it has "a longstanding commitment to develop and apply innovative approaches to the regulation of medical device software and other digital health devices" and that it supports continued consideration of least burdensome approaches that could speed the availability of safe and effective devices. The petition and FDA's response are in docket FDA-2025-P-5560.