FDA Exempts AI X-Ray Gadgets from Paperwork—Snore Fest
Published Date: 9/17/2026
Rule
Summary
The Food and Drug Administration (FDA) is publishing an order setting forth its final determination regarding a partial exemption from the premarket notification requirements for radiology computer- aided detection and/or diagnosis devices and computer-aided triage and notification devices that was the subject of a notice published in the Federal Register of December 29, 2025. That notice announced FDA's receipt of a petition that requested exemption from the premarket notification requirements for the following generic device types when certain conditions described in the petition were met: radiological computer-assisted diagnostic software for lesions suspicious of cancer; medical image analyzers; radiological computer aided triage and notification software; and radiological computer-assisted detection and diagnosis software. FDA denied the petition in a response issued to the petitioner on April 1, 2026. FDA is publishing this order in accordance with procedures established by the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Analyzed Economic Effects
2 provisions identified: 0 benefits, 2 costs, 0 mixed.
No 510(k) Exemption for Radiology AI
If you make radiology computer-aided detection/diagnosis (CAD/CADe/CADx) or computer-aided triage and notification (CADt) devices classified under 21 CFR 892.2060, 892.2070, 892.2080, or 892.2090 (product codes POK, MYN, QAS, QFM, QBS, QDQ), FDA denied a petition and you must continue to submit and receive a 510(k) premarket notification before marketing. FDA denied the petition by letter dated April 1, 2026, and issued this final order effective September 17, 2026.
Ongoing Quality and Listing Requirements
Manufacturers of the Subject CAD and CADt devices must also continue to comply with other applicable FD&C Act requirements, including existing special controls, quality systems (21 CFR part 820), establishment registration and device listing, labeling (21 CFR part 801), investigational device exemptions (21 CFR part 812), and postmarket surveillance (21 CFR part 822). This obligation remains in force as of the final order effective September 17, 2026.
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