FDA finalizes Class II classification for cardiovascular ML notification software
Under review: a routine re-check found that the government record may have changed since this entry was written. It is being checked and will be corrected if needed (since 2026-10-27).
The FDA has finalized a rule classifying cardiovascular machine learning-based notification software as a Class II medical device. Published in the Federal Register on September 11, 2026, the order is effective the same day, and this action places the software under special controls rather than the stricter Class III pathway. The agency states this classification provides reasonable assurance of safety and effectiveness while reducing regulatory burdens to improve patient access. Healthcare organizations using or deploying this type of AI-driven notification tool should review the specific special controls identified in the rule to ensure compliance. This final rule applies to manufacturers and developers of these cardiovascular devices.