Fed Regist. 2016 Jun 21;81(119):40181-3.
The Food and Drug Administration (FDA) is classifying the gynecologic laparoscopic power morcellation containment system into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the gynecologic laparoscopic power morcellation containment system's classification. 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.
美国食品药品监督管理局（FDA）正在将妇科腹腔镜动力旋切术 containment 系统归类为 II 类（特殊控制）。适用于该设备的特殊控制措施在本指令中予以确定，并将成为妇科腹腔镜动力旋切术 containment 系统分类的法典语言的一部分。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。
