FDA Eases Path for AI Radiology Tools
Published Date: 6/17/2026
Rule
Summary
The FDA is officially putting radiology software that uses machine learning and has a set plan for updates into a safer, easier-to-manage category called Class II. This change helps make sure the software is safe and effective while speeding up patient access to cool new tech. It’s been effective since early 2023, so companies can expect fewer hoops to jump through without extra costs or delays.
Analyzed Economic Effects
4 provisions identified: 2 benefits, 1 costs, 1 mixed.
Radiology ML Software Now Class II
The FDA has classified radiological machine learning-based quantitative imaging software with a predetermined change control plan as Class II (special controls). The order is effective June 17, 2026, and the classification has been applicable since February 24, 2023.
Creates Predicate for Future Devices
Because FDA classified this device type via the De Novo process, the device can serve as a predicate for future devices of that type. That lets other device sponsors use the less burdensome 510(k) process instead of submitting a De Novo request or a premarket approval application.
Premarket 510(k) Notification Required
The rule states that this device type is subject to premarket notification requirements under section 510(k) of the Federal Food, Drug, and Cosmetic Act unless FDA later exempts it under section 510(m).
New Technical and Labeling Requirements
The final order establishes special controls including: detailed design verification and validation (algorithm descriptions, training data details, independent test datasets, objective performance measures), documentation of planned modifications under the predetermined change control plan (PCCP), risk identification and mitigation for planned modifications, and labeling requirements (patient population, intended user, inputs/outputs, compatible hardware/protocols, performance summary with confidence intervals, failure situations, and PCCP details including version history).
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