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comment_72008

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

  • Yes. You could give the red cells and the plasma to your NICU and let them transfuse as they wish.

  • David Saikin
    David Saikin

    Agree w the above.  Reconstituted whole blood is a manufactured product. 

comment_72009

Yes.

You could give the red cells and the plasma to your NICU and let them transfuse as they wish.

Edited by AMcCord

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

 

comment_72017

Agree w the above.  Reconstituted whole blood is a manufactured product. 

  • 4 weeks later...
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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