Fed Regist. 2018 Oct 19;83(203):52970-72.
The Food and Drug Administration (FDA or we) is classifying the hemostatic device for intraluminal gastrointestinal use 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 hemostatic device for intraluminal gastrointestinal use'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）正在将用于腔内胃肠道的止血装置分类为II类（特殊控制）。适用于该装置类型的特殊控制措施在本指令中予以确定，并将成为用于腔内胃肠道的止血装置分类的编纂语言的一部分。我们采取这一行动是因为我们已确定将该装置分类为II类（特殊控制）将为该装置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装置的机会。
