The U.S. Food and Drug Administration (FDA) has opened comment on a citizen petition seeking a new streamlined regulatory pathway for radiology AI software.
The petition calls for vendors who have already received 510(k) clearances for radiology AI software to be able to comply with postmarket study requirements instead of submitting new 510(k) applications for new capabilities. The traditional 510(k) pathway would also still be available.
In its summary, the FDA highlighted key points of a document submitted by Rubrum Advising on behalf of Harrison.ai to exempt four generic device types when certain conditions are met. The petition encompasses the following device types:
- Radiological computer-assisted diagnostic (CADx) software for lesions suspicious of cancer, classified under § 892.2060 (21 CFR 892.2060), product code POK.
- Medical image analyzers, classified under § 892.2070 (21 CFR 892.2070), product code MYN.
- Radiological computer-aided triage (CADt) and notification software, classified under § 892.2080 (21 CFR 892.2080), product codes QAS and QFM.
- Radiological computer-assisted detection and diagnosis (CADe/x) software, classified under § 892.2090 (21 CFR 892.2090), product codes QBS and QDQ.
Existing policy already considers device history of false or misleading claims and risks associated with inherent device characteristics, safe and effective performance, and changes in the device that could affect safety and effectiveness or that would not be likely to result in a change in the device's classification, according to the FDA.
However, the October 21, 2025, petition highlights a radiology AI "innovation gap" between the U.S. and Europe that restricts broader AI adoption and utilization across healthcare systems.
Difference between the number and nature of AI diagnostic findings available in the U.S. (red) and U.K., EU, and Asia (black). Slide reproduced from Keith Dreyer, MD’s presentation to the FDA Digital Health Advisory Committee on Total Product Lifecycle Considerations for Generative Artificial Intelligence-Enabled Medical Devices, November 20, 2024 (Dreyer, 2024).Rubrum Advising via FDA
Manufacturers often significantly limit their product’s full offering for the U.S. market, seeking FDA clearance for a limited range of applications such as specific imaging modalities with narrowly defined diagnostic tasks, the petition explained, adding that the U.S. regulatory pathway is burdensome and ill-suited to the rapidly evolving nature of AI compared with Europe.
"The focus of this petition is AI diagnostic tools -- software as a medical device (SaMD) used in radiology -- that are regulated by the FDA under the 510(k) program," the petition noted.
First, the petition requests exemption from premarket notification, 510(k) submission requirements for CADx, CADe/x, CADt, and MYN devices when the manufacturer has previously obtained a 510(k), and further highlights the following conditions:
- For devices under § 892.2080, the manufacturer must have at least one clearance under the same classification regulation.
- For devices under § 892.2060, 892.2070, or 892.2090, the manufacturer must have at least one clearance under any of those same three classification regulations.
- The manufacturer must implement a robust post-market plan, transparency, and training measures as described in the petition.
In addition, all existing special controls, quality systems, establishment registration, and device listing requirements would remain in force, according to the FDA's summary.
Ultimately, the petition proposes a new regulatory pathway -- a streamlined, partially 510(k)-exempt pathway for radiology AI -- that builds on a solution proposed under the first Trump administration. The existing 510(k) pathway would remain in place; however, the partial 510(k) exemption, to include limitations, would also be available, according to the proposal.
"If the manufacturer has at least one prior 510(k) clearance for a device that falls under the CADt regulation (21 CFR 892.2080), the partial exemption would apply to future products under that same regulation," the proposal explained. "A CADt clearance could not be leveraged for future exemption of a CADx, CADe, or CADe/x product."
"If the manufacturer has at least one prior 510(k) clearance for a device under the CADx (21 CFR 892.2060), CADe (21 CFR 892.2070), or CADe/x (21 CFR 892.2090) regulations, the partial exemption would apply to future products that fall under any of those three regulations," the proposal continued. "This is appropriate because the special controls currently applicable to CADx, CADe, and CADe/x are largely aligned, with all the same key elements."
Importantly, this proposed pathway is within the FDA’s existing authority to implement, authors noted, adding that the FDA exercised partial exemption authority in 2018 and has express statutory authority under section 513(a)(1)(B) to issue postmarket surveillance as a special control. Furthermore, the petition aligns with establishing a dynamic, “try-first” culture for AI across American industry, according to the authors.
Electronic or written comments must be submitted by February 27, 2026. Find the FDA summary in the December 29, 2025, edition of the Federal Register.
