FDA Rejects Exemptions for Radiology AI Devices
Published Date: 9/17/2026
Rule
Summary
The FDA has decided NOT to exempt certain radiology computer software devices from premarket review, meaning these devices still need FDA approval before hitting the market. This affects companies making cancer detection and medical image analysis software, keeping safety checks in place. The rule takes effect on September 17, 2026, so businesses should plan accordingly to avoid delays or extra costs.
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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