Fed Regist. 2005 Sep 20;70(181):55026-8.
The Food and Drug Administration (FDA) is classifying the oral rinse to reduce the adhesion of dental plaque device into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Oral Rinse to Reduce the Adhesion of Dental Plaque." The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a guidance document that is the special control for this device.
美国食品药品监督管理局（FDA）正在将用于减少牙菌斑黏附的漱口水装置归类为II类（特殊控制）。适用于该装置的特殊控制是一份名为《II类特殊控制指南文件：减少牙菌斑黏附的漱口水》的指南文件。该机构将该装置归类为II类（特殊控制），以便合理保证该装置的安全性和有效性。在本期《联邦公报》的其他地方，FDA发布了一份指南文件的可用性通知，该文件是该装置的特殊控制。
