# Cardiovascular Devices; Reclassification of External Pacemaker Pulse Generator Devices; Reclassification of Pacing System Analyzers
> **Food and Drug Administration** · Final order. · Published 2016-04-18 · Effective 2016-04-18 · 81 FR 22525
## Document
- **Document number:** 2016-08898
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 81 FR 22525
- **CFR reference:** 21 CFR 870
- **Publication date:** 2016-04-18
- **Effective date:** 2016-04-18
- **HHS docket:** Docket No. FDA-2011-N-0650
## Abstract

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.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2016/04/18/2016-08898/cardiovascular-devices-reclassification-of-external-pacemaker-pulse-generator-devices)
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