FDA Classifies AI Software for Cardiovascular Alerts
Published Date: 9/11/2026
Rule
Summary
The Food and Drug Administration (FDA) is classifying the cardiovascular machine learning-based notification software into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the cardiovascular machine learning- based notification software. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Analyzed Economic Effects
4 provisions identified: 2 benefits, 2 costs, 0 mixed.
Class II Rule May Improve Patient Access
The FDA has classified cardiovascular machine learning-based notification software as Class II (special controls), effective September 11, 2026, with the classification applicable on August 3, 2023. FDA states this classification will reduce regulatory burdens and "enhance patients' access to beneficial innovative devices," which may make these non-diagnostic cardiovascular decision‑support tools more available to patients.
Premarket 510(k) Required for Devices
FDA states cardiovascular machine learning-based notification software remains subject to premarket notification under section 510(k) of the FD&C Act. Companies seeking to market this Class II device must submit a 510(k) unless FDA later determines the device type should be exempt under section 510(m).
New Special Controls Add Testing & Labeling Rules
Manufacturers must meet new special controls including clinical performance testing using real‑world test datasets (independent from training data), subgroup analyses, objective performance measures, and a test dataset that includes a minimum of three geographically diverse sites. They must also perform software verification/validation, human factors assessment, and include detailed labeling (limitations, warnings, supported sensors, and expected minimum performance).
De Novo Classification Enables 510(k) Predicates
FDA states that because this device was classified via the De Novo process, the device type can serve as a predicate for future devices of the same type, allowing subsequent sponsors to use the less burdensome 510(k) pathway instead of De Novo or premarket approval. FDA notes this consequence in its discussion of the De Novo classification process.
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