Dental devices; classification for intraoral devices for snoring and/or obstructive sleep apnea. Final rule.
The Food and Drug Administration (FDA) is classifying the intraoral devices for snoring and/or obstructive sleep apnea into class II (special controls). These devices are used to control or treat simple snoring and/or obstructive sleep apnea. This classification is based on the recommendations of the Dental Devices Panel (the Panel), and is being taken to establish sufficient regulatory controls that will provide reasonable assurance of the safety and effectiveness of these devices. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (the SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA). Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of the guidance document that will serve as the special control for this final rule.
D003742:Dental Devices, Home Care / Q000145:classification*; D018795:Device Approval; D004867:Equipment Design / Q000145:classification; D004869:Equipment Safety / Q000145:classification; D006801:Humans; D020181:Sleep Apnea, Obstructive / Q000628:therapy*; D012913:Snoring / Q000628:therapy*; D014481:United States; D014486:United States Food and Drug Administration