FDA classifies cardiovascular machine learning-based notification software into class II with special controls
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Summary
The Food and Drug Administration issued a final order classifying cardiovascular machine learning-based notification software into class II (special controls) and codifying it at 21 CFR 870.2380. The device type uses machine learning to suggest the likelihood of a cardiovascular condition for further referral or follow-up. The order follows a De Novo request received from Viz.ai, Inc. on January 10, 2023, with the classification applicable on August 3, 2023. Special controls cover clinical performance testing, software verification and validation, human factors assessment and labeling. The device remains subject to premarket notification requirements under section 510(k) of the FD&C Act. The order is effective September 11, 2026.
Why it matters
Developers of machine learning-based cardiovascular notification software now have a defined class II pathway with specific special controls, including testing on independent datasets from geographically diverse sites and labeling warnings. Future similar devices can use the classified device as a predicate and the less burdensome premarket notification process under 510(k) instead of a De Novo request.
- Parties involved
- Food and Drug Administration; Viz.ai, Inc.
- Federal Register doc. no.
- 2026-18612
- Citation
- 91 FR 57785
- Docket number
- FDA-2026-N-9907
- Primary source
- Federal Register (US) (federalregister.gov)
Source retrieved: . Sources are often in other languages; links open the original. - Topics
- Healthcare & medical AI