FOOD AND DRUG ADMINISTRATION ISSUES RULE: MEDICAL DEVICES; ANESTHESIOLOGY DEVICES; CLASSIFICATION OF THE OVER-THE-COUNTER DEVICE TO ASSESS RISK OF SLEEP APNEA

WASHINGTON, Oct. 30 -- Food and Drug Administration has issued a rule called: Medical Devices; Anesthesiology Devices; Classification of the Over-the-Counter Device To Assess Risk of Sleep Apnea.

The rule was published in the Federal Register on Oct. 30 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA) is classifying the over-the-counter device to assess risk of sleep apnea 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 over-the-counter device to assess risk of sleep apnea. We are taking this action because we have de...