Fed Regist. 2016 May 25;81(101):33128-34.
The Food and Drug Administration (FDA) is issuing a final order to reclassify external cardiac compressors (ECC) (under FDA product code DRM), a preamendments class III device, into class II (special controls). FDA is also creating a separate classification regulation for a subgroup of devices previously included within this classification regulation, to be called cardiopulmonary resuscitation (CPR) aids, and reclassifying these devices from class III to class II for CPR aids with feedback and to class I for CPR aids without feedback.
美国食品药品监督管理局（FDA）正在发布一项最终命令，将外部心脏按压设备（ECC）（FDA产品代码为DRM），一种修正案前的III类设备，重新分类为II类（特殊控制）。FDA还将为先前包含在该分类规则中的一类设备制定单独的分类规则，这类设备将被称为心肺复苏（CPR）辅助设备，并将这些设备从III类重新分类为具有反馈功能的CPR辅助设备的II类以及无反馈功能的CPR辅助设备的I类。
