WASHINGTON, July 24 -- Food and Drug Administration has issued a rule called: Medical Devices; General Hospital and Personal Use Devices; Classification of the Diabetes Digital Behavioral Therapeutic Device.
The rule was published in the Federal Register on July 24 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.
Summary: The Food and Drug Administration (FDA) is classifying the diabetes digital behavioral therapeutic device 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 diabetes digital behavioral therapeutic device. We are taking this action because we have dete...