WASHINGTON, April 30 -- Food and Drug Administration has issued a rule called: Medical Devices; Neurological Devices; Classification of the Brain Temperature Measurement System.
The rule was published in the Federal Register on April 30 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.
Summary: The Food and Drug Administration (FDA) is classifying the brain temperature measurement system 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 brain temperature measurement system. We are taking this action because we have determined that classifying the device into class II ...