FOOD AND DRUG ADMINISTRATION ISSUES RULE: MEDICAL DEVICES; ANESTHESIOLOGY DEVICES; CLASSIFICATION OF THE DEVICE FOR SLEEP APNEA TESTING BASED ON MANDIBULAR MOVEMENT

WASHINGTON, April 22 -- Food and Drug Administration has issued a rule called: Medical Devices; Anesthesiology Devices; Classification of the Device for Sleep Apnea Testing Based on Mandibular Movement.

The rule was published in the Federal Register on April 22 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA) is classifying the device for sleep apnea testing based on mandibular movement 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 device for sleep apnea testing based on mandibular movement. We are taking this actio...