Posted January 4, 20187 yr comment_72008 Does anyone know if FDA registration is required if a hospital reconstitutes RBCs with plasma for a Neonatal exchange transfusion?
January 4, 20187 yr comment_72009 Yes. You could give the red cells and the plasma to your NICU and let them transfuse as they wish. Edited January 4, 20187 yr by AMcCord
January 4, 20187 yr comment_72012 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
January 5, 20187 yr comment_72017 Agree w the above. Reconstituted whole blood is a manufactured product.
January 28, 20187 yr comment_72318 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!
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