Fed Regist. 2005 Mar 10;70(46):11867-9.
The Food and Drug Administration (FDA) is classifying instrumentation for clinical multiplex test systems 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: Instrumentation for Clinical Multiplex Test Systems." 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）正在将临床多重检测系统的仪器设备归类为II类（特殊控制）。适用于该设备的特殊控制是题为《II类特殊控制指南文件：临床多重检测系统的仪器设备》的指南文件。该机构将该设备归类为II类（特殊控制），以便合理保证该设备的安全性和有效性。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，该文件是该设备的特殊控制文件。
