In the September 15, 2014, Federal Register, FDA withdrew a 2011 proposed rule and associated guidance document that sought to reclassify external pacemaker pulse generator ("EPPG") devices, a preamendments class III device, into class II (special controls). FDA simultaneously issued a proposed administrative order that seeks the same reclassification described in the withdrawn proposed rule. This substitution of an administrative order in place of a proposed rule reflects FDASIA's changes to FDA's device reclassification process, shifting it from a rulemaking process to an administrative order process. In the proposed order, FDA also proposes to amend the device identification and reclassify pacing system analyzers ("PSAs") into class II (special controls). Specifically, FDA proposes to reclassify as Class II devices single- and dual-chamber PSAs, which are currently classified with EPPG devices, and triple-chamber PSAs, which are postamendments class III devices. FDA is proposing this reclassification based on new information pertaining to the device. FDA states the proposed action would implement certain statutory requirements. Comments due December 15, 2014.
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