FDA classifies cardiovascular machine-learning-based notification software as Class II medical device

The FDA published a final order in the Federal Register on September 11, 2026 classifying 'cardiovascular machine learning-based notification software' into Class II (special controls). The order is effective September 11, 2026, though the underlying classification determination was applicable as of August 3, 2023 (via an earlier De Novo pathway now being codified).

This creates a defined regulatory category and special-controls pathway specifically for ML-based cardiovascular notification software, giving device manufacturers a predictable premarket route, but it is narrow in scope — affecting only this specific device class rather than AI governance broadly.

Manufacturers of cardiovascular ML notification software should review the special controls identified in the order to ensure premarket submissions align with the new classification requirements.