Fed Regist. 2007 Apr 24;72(78):20225-7.
The Food and Drug Administration (FDA) is classifying the computerized labor monitoring systems into class II (special controls). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled, "Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Computerized Labor Monitoring Systems," which will serve as the special controls for these devices. The agency is classifying these devices into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of these devices.
美国食品药品监督管理局（FDA）正在将计算机化产程监测系统归类为II类（特殊控制）。在本期《联邦公报》的其他地方，FDA宣布可获取一份题为《行业和FDA工作人员指南；II类特殊控制指南文件：计算机化产程监测系统》的指南文件，该文件将作为这些设备的特殊控制措施。该机构将这些设备归类为II类（特殊控制），以便合理保证这些设备的安全性和有效性。
