Cardiopulmonary bypass components downclassification under consideration by FDA.
This article was originally published in The Gray Sheet
Executive Summary
CARDIOPULMONARY BYPASS CIRCUIT DEVICES DOWNCLASSIFICATION may be possible based on information already gathered by FDA to support reclassification for centrifugal blood pumps, according to the agency. FDA is exploring the use of device data and special controls already developed for downclassification of centrifugal blood pumps from Class III to Class II as the basis for downclassifying defoamers, arterial line blood filters, oxygenators, and pulsatile flow generators, which also are components of the cardiopulmonary bypass circuit.