Fed Regist. 2018 Oct 17;83(201):52315-6.
The Food and Drug Administration (FDA or we) is classifying the external upper limb tremor stimulator 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 external upper limb tremor stimulator'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）正在将外部上肢震颤刺激器归类为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确定，并且将成为外部上肢震颤刺激器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，将该器械归类为II类（特殊控制）将为该器械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器械的机会。
