Jump to content

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

5GAM
in Computer Systems / Software / ISBT128

Featured Replies

Posted
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. 

  • 5 weeks later...
  • Replies 2
  • Views 1.1k
  • Created
  • Last Reply

Top Posters In This Topic

Popular Days

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.

Create an account or sign in to comment

Go to topic listing

Recently Browsing 0

  • No registered users viewing this page.

Important Information

We have placed cookies on your device to help make this website better. You can adjust your cookie settings, otherwise we'll assume you're okay to continue.