FDA Mulls Skipping Approvals for Radiology AI Aids
Published Date: 12/29/2025
Notice
Summary
The FDA is considering letting some radiology software devices skip the usual premarket approval process to speed up their availability. This affects companies making computer-aided detection, diagnosis, triage, and notification tools used in medical imaging. If approved, it could save time and money, and the public can comment on this change until February 27, 2026.
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
Petition to Exempt Radiology AI From 510(k)
The FDA received a petition asking that certain radiology software — including radiological computer-assisted diagnostic software for lesions suspicious of cancer (21 CFR 892.2060, product code POK), medical image analyzers (21 CFR 892.2070, product code MYN), radiological computer-aided triage and notification software (21 CFR 892.2080, product codes QAS and QFM), and radiological computer-assisted detection and diagnosis software (21 CFR 892.2090, product codes QBS and QDQ) — be partially exempt from the 510(k) premarket notification when specific conditions are met. The petition’s conditions include that the manufacturer previously obtained a 510(k) (with device-specific clearance rules for the listed sections), implementation of a robust post-market plan plus transparency and training measures, and that existing special controls, quality systems, establishment registration, and device listing requirements remain in force. Comments on the petition are due by February 27, 2026.
Statutory Timelines Could Auto-Grant Petition
Under the FD&C Act and the 21st Century Cures Act process cited in the notice, FDA must publish an order with its final determination within 120 days after this notice; if FDA fails to respond to a petition within 180 days of receiving it, the petition is deemed granted. Interested parties may submit comments through February 27, 2026.
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