Fed Regist. 2017 Dec 28;82(248):61446-8.
The Food and Drug Administration (FDA or we) is classifying the pressure wedge for the reduction of cesarean delivery into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the pressure wedge for the reduction of cesarean delivery's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
美国食品药品监督管理局（FDA或我们）正在将用于降低剖宫产率的压力楔归为II类（特殊控制）。适用于该器械类型的特殊控制措施在本指令中予以明确，将成为用于降低剖宫产率的压力楔分类的编入法典语言的一部分。我们采取这一行动是因为我们已确定将该器械归为II类（特殊控制）将为器械的安全性和有效性提供合理保证。我们认为这一行动还将部分通过减轻监管负担来增加患者获得有益创新器械的机会。
