Medical Devices; Anesthesiology Devices; Classification of Devices to Relieve Upper Airway Obstruction

The Food and Drug Administration (FDA) is classifying devices to relieve upper airway obstruction into class II (special controls). The special control that will apply to this device is a labeling and design control guidance document. This action is being taken in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976 (the amendments), the Safe Medical Devices Act of 1990 (the SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA). The agency is classifying this device into class II in order to provide a reasonable assurance of the safety and effectiveness of the device.