FDA classifies radiological machine learning imaging software with change control plan as class II
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Summary
The Food and Drug Administration issued a final order classifying radiological machine learning-based quantitative imaging software with a predetermined change control plan into class II (special controls). The order codifies 21 CFR 892.2055. The device is a software-only product using machine learning algorithms on radiological images for quantitative outputs such as view selection, segmentation and landmarking. The special controls cover design verification and validation, including training data description and independent test data, documentation and risk management of planned modifications, and labeling. The classification followed a De Novo request received on September 28, 2022 from Caption Health, Inc. and was applicable from February 24, 2023. The order is effective June 17, 2026.
Why it matters
Developers of this type of device now have codified special controls to meet, and the device can serve as a predicate for future devices. The document states the device remains subject to premarket notification requirements under section 510(k) of the FD&C Act, since no exemption was determined.
- Parties involved
- Food and Drug Administration; Department of Health and Human Services; Caption Health, Inc.
- Federal Register doc. no.
- 2026-12166
- Citation
- 91 FR 36522
- Docket number
- FDA-2026-N-6535
- Primary source
- Federal Register (US) (federalregister.gov)
Source retrieved: . Sources are often in other languages; links open the original. - Topics
- Healthcare & medical AI