Fed Regist. 2018 Feb 5;83(24):5033-5.
The Food and Drug Administration (FDA or we) is classifying the percutaneous nerve stimulator for substance use disorders 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 percutaneous nerve stimulator for substance use disorders' 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）正在将用于物质使用障碍的经皮神经刺激器归类为II类（特殊控制）。适用于该设备类型的特殊控制在本指令中予以确定，并且将成为用于物质使用障碍的经皮神经刺激器分类的编入法典的语言的一部分。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来增加患者获得有益创新设备的机会。
