FOOD AND DRUG ADMINISTRATION ISSUES RULE: MEDICAL DEVICES; ANESTHESIOLOGY DEVICES; CLASSIFICATION OF THE MONITOR FOR OPIOID INDUCED IMPAIRMENT OF OXYGENATION

WASHINGTON, June 30 -- Food and Drug Administration has issued a rule called: Medical Devices; Anesthesiology Devices; Classification of the Monitor for Opioid Induced Impairment of Oxygenation.

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

Summary: The Food and Drug Administration (FDA) is classifying the monitor for opioid induced impairment of oxygenation 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 monitor for opioid induced impairment of oxygenation. We are taking this action because we have deter...