FDA Down-Classifies External Pacemaker Pulse Generator Devices and PSAs

Friday, April 15, 2016

Source: Regulatory Affairs Professional Society

The Food and Drug Administration (FDA) on Friday released a final order to reclassify external pacemaker pulse generator (EPPG) devices and pacing system analyzers (PSAs), which are currently class III devices, into class II (special controls).

The 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 post-amendments class III devices, into that new classification regulation. FDA is also making a slight modification to identify EPPG devices as prescription devices.

View All News »