TMOSLEY Posted January 4, 2018 Share Posted January 4, 2018 Does anyone know if FDA registration is required if a hospital reconstitutes RBCs with plasma for a Neonatal exchange transfusion? Link to comment Share on other sites More sharing options...
AMcCord Posted January 4, 2018 Share Posted January 4, 2018 (edited) Yes. You could give the red cells and the plasma to your NICU and let them transfuse as they wish. Edited January 4, 2018 by AMcCord mcgouc and Eman 1 1 Link to comment Share on other sites More sharing options...
simret Posted January 4, 2018 Share Posted January 4, 2018 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 tricore, Eagle Eye, Eman and 1 other 4 Link to comment Share on other sites More sharing options...
David Saikin Posted January 5, 2018 Share Posted January 5, 2018 Agree w the above. Reconstituted whole blood is a manufactured product. exlimey 1 Link to comment Share on other sites More sharing options...
Eagle Eye Posted January 28, 2018 Share Posted January 28, 2018 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! Link to comment Share on other sites More sharing options...
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