The FDA issued a final order reclassifying nonroller-type cardiopulmonary and circulatory bypass blood pumps from Class III to Class II with special controls.
NRP devices for temporary ventricular support will remain in Class III and require PMAs.
The special controls for NPRs cardiopulmonary and circulatory bypass include nonclinical performance testing showing durability, proof of biocompatibility, sterility testing and proper labeling including safety warnings.
The order finalizes a Jan. 7, 2014, proposed order that followed a unanimous advisory panel recommendation in December 2012 for downclassification of non-ventricular support NRPs. The panel based its recommendation on the devices’ long history of use in bypass procedures.