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Neonatal Exchange-FDA Registration

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Does anyone know if FDA registration is required if a hospital reconstitutes RBCs with plasma for a Neonatal exchange transfusion?

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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

 

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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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