Fed Regist. 2016 Apr 18;81(74):22525-30.
The Food and Drug Administration (FDA) is issuing a final order to reclassify external pacemaker pulse generator (EPPG) devices, which are currently preamendments class III devices (regulated under product code DTE), into class II (special controls) and to reclassify pacing system analyzers (PSAs) into class II (special controls) based on new information and subject to premarket notification. This final order also creates a separate classification regulation for PSAs and places single and dual chamber PSAs, which are currently classified with EPPG devices, and triple chamber PSAs (TCPSAs), which are currently postamendments class III devices, into that new classification regulation.
美国食品药品监督管理局（FDA）正在发布一项最终命令，将外部起搏器脉冲发生器（EPPG）设备重新分类，该设备目前属于修正案前的III类设备（根据产品代码DTE进行监管），重新分类为II类（特殊控制），并将起搏系统分析仪（PSA）重新分类为II类（特殊控制），这是基于新信息并需进行上市前通知。该最终命令还为PSA制定了单独的分类规定，并将目前与EPPG设备分类在一起的单腔和双腔PSA以及目前属于修正案后III类设备的三腔PSA（TCPSA）纳入该新分类规定。
