Fed Regist. 2017 Jan 6;82(4):1598-603.
The Food and Drug Administration (FDA or the Agency) is reclassifying surgical instrumentation for use with urogynecologic surgical mesh from class I (general controls) exempt from premarket notification to class II (special controls) and subject to premarket notification, and identifying them as "specialized surgical instrumentation for use with urogynecologic surgical mesh." FDA is designating special controls that are necessary to provide a reasonable assurance of safety and effectiveness of the device. FDA is reclassifying this device on its own initiative based on new information.
美国食品药品监督管理局（FDA或该机构）正在将用于泌尿妇科手术网片的手术器械从豁免上市前通知的I类（一般控制）重新分类为II类（特殊控制）并需进行上市前通知，并将其认定为“用于泌尿妇科手术网片的专用手术器械”。FDA正在指定必要的特殊控制措施，以合理保证该器械的安全性和有效性。FDA根据新信息自行主动对该器械进行重新分类。
