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Question FDA guidance "Recognition and Use of a Standard for Uniform Blood and Blood Component Container Labels"

5GAM
in Computer Systems / Software / ISBT128

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comment_88955

Hello Group,

I am new to the transfusion area and just came across this document. I would like to know what is the process to determine if the recently released FDA guidance (regarding ISTBT v4.0.0) is applicable to blood bank lab.  Thank you  and appreciate any help. 

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comment_89338

Yes.  Here's a link to the AABB article: REGULATORY UPDATE: FDA Recognizes ISBT Version 4.0.0 as Acceptable for Use (aabb.org)

comment_89363

Correct me if I'm wrong but this version 4.0.0 update only applies to licensed manufacturers.  It would apply if your Blood Bank lab is licensed and manufactures blood and blood products.

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