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.
You may also be interested in...
Deal Watch: AbbVie Teams With MedinCell On Long-Acting Injectables
Collaboration Edition: Including deals involving Evotec/Variant, Sanofi/IGM/Nurix, ABVC/OncoX and Harmony/Bioprojet, along with tech transfer agreements and deals in brief.
GE HealthCare Launches AI-Powered Voluson Ultrasound For Women’s Health
Voluson Signature 20 and 18 ultrasound provides clinicians with workflow efficiencies in detecting female reproductive health problems, especially those related to pregnancy.
CDER, CBER Not Seeing Hiring Slowdown Despite US FDA Warnings
FDA officials have said hiring could be slowed if an inflationary pay increase is not included in the agency budget, but CDER and CBER continue to add staff at a steady pace.