Fed Regist. 2002 Nov 12;67(218):68510-2.
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.
美国食品药品监督管理局（FDA）正在将用于治疗打鼾和/或阻塞性睡眠呼吸暂停的口腔内装置分类为II类（特殊控制）。这些装置用于控制或治疗单纯性打鼾和/或阻塞性睡眠呼吸暂停。这一分类是基于牙科器械小组（该小组）的建议，并采取该分类以建立充分的监管控制，从而为这些装置的安全性和有效性提供合理保证。此行动是根据经1976年《医疗器械修正案》（1976年修正案）、1990年《安全医疗器械法案》（SMDA）和1997年《食品药品管理局现代化法案》（FDAMA）修订的《联邦食品、药品和化妆品法案》（该法案）采取的。在本期《联邦公报》的其他地方，FDA发布了一份指导文件可用性通知，该文件将作为本最终规则的特殊控制措施。
