Fed Regist. 2018 Mar 7;83(45):9698-700.
The Food and Drug Administration (FDA or we) is classifying the extracorporeal shock wave device for treatment of chronic wounds 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 extracorporeal shock wave device for treatment of chronic wounds' 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）正在将用于治疗慢性伤口的体外冲击波设备归类为II类（特殊控制）。适用于该设备类型的特殊控制措施在本指令中予以确定，并将成为用于治疗慢性伤口的体外冲击波设备分类的编码语言的一部分。我们采取这一行动是因为我们已经确定，将该设备归类为II类（特殊控制）将为该设备的安全性和有效性提供合理保证。我们相信，这一行动还将部分通过减轻监管负担，增加患者获得有益创新设备的机会。
