# Cardiovascular Devices; Reclassification of External Cardiac Compressor; Reclassification of Cardiopulmonary Resuscitation Aids
> **Food and Drug Administration** · Final order. · Published 2016-05-25 · Effective 2016-05-25 · 81 FR 33128
## Document
- **Document number:** 2016-12333
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 81 FR 33128
- **CFR reference:** 21 CFR 870
- **Publication date:** 2016-05-25
- **Effective date:** 2016-05-25
- **HHS docket:** Docket No. FDA-2012-N-1173
## Abstract

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.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2016/05/25/2016-12333/cardiovascular-devices-reclassification-of-external-cardiac-compressor-reclassification-of)
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