TMOSLEY 10 Report post Posted January 4 Does anyone know if FDA registration is required if a hospital reconstitutes RBCs with plasma for a Neonatal exchange transfusion? Share this post Link to post Share on other sites
AMcCord 965 Report post Posted January 4 (edited) Yes. You could give the red cells and the plasma to your NICU and let them transfuse as they wish. Edited January 4 by AMcCord 1 1 mcgouc and Eman reacted to this Share this post Link to post Share on other sites
simret 17 Report post Posted January 4 Yes you do! In accordance with 21 CFR 607.21, you must register and list the blood products you manufacture ( when you reconstitute, you are manufacturing a new product = whole blood ( new ISBT #) for commercial distribution every year between October 1 and December 31 and you must update your blood product listing every June and December. I hope that helps. Simret 4 exlimey, tricore, Eagle Eye and 1 other reacted to this Share this post Link to post Share on other sites
David Saikin 1,148 Report post Posted January 5 Agree w the above. Reconstituted whole blood is a manufactured product. 1 exlimey reacted to this Share this post Link to post Share on other sites
Eagle Eye 195 Report post Posted January 28 Yes. If you combine plasma and red blood cells in your blood bank you need to register with FDA and be ready for FDA inspections! Share this post Link to post Share on other sites
