Cardiovascular Devices; Reclassification of External Cardiac Compressor; Reclassification of Cardiopulmonary Resuscitation Aids
other · Food and Drug Administration · Rule · Published 2016-05-25 · Effective 2016-05-25 · 81 FR 33128
Document
Document number
2016-12333
Federal Register citation
81 FR 33128
CFR reference
21 CFR 870
Type
Rule
Action
Final order.
Category
other
Sub-agency
Food and Drug Administration
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.