FOOD AND DRUG ADMINISTRATION ISSUES RULE: MEDICAL DEVICES; CARDIOVASCULAR DEVICES; CLASSIFICATION OF THE CARDIOVASCULAR MACHINE LEARNING-BASED NOTIFICATION SOFTWARE

WASHINGTON, Sept. 11 -- Food and Drug Administration has issued a rule called: Medical Devices; Cardiovascular Devices; Classification of the Cardiovascular Machine Learning-Based Notification Software.

The rule was published in the Federal Register on Sept. 11 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

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 actio...