Cardiovascular Devices; Reclassification of Nonroller-Type Cardiopulmonary Bypass Blood Pumps for Cardiopulmonary and Circulatory Bypass; Effective Date of Requirement for Premarket Approval for Nonroller-Type Cardiopulmonary Bypass Blood Pumps for Temporary Ventricular Support
fda-device · Food and Drug Administration · Rule · Published 2015-06-08 · Effective 2015-06-08 · 80 FR 32307
Document
Document number
2015-13889
Federal Register citation
80 FR 32307
CFR reference
21 CFR 870
Type
Rule
Action
Final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2015-06-08
Effective date
2015-06-08
HHS docket
Docket No. FDA-2013-N-1518
Abstract
The Food and Drug Administration (FDA) is issuing a final order to reclassify nonroller-type cardiopulmonary bypass blood pump (NRP) devices for cardiopulmonary and circulatory bypass, a preamendments class III device, into class II (special controls), and to require the filing of a premarket approval application (PMA) for NRP devices for temporary ventricular support. FDA is also revising the title and identification of the regulation for NRP devices in this order.