12/13 March 2024
In June 2014, the FDA published a Guidance for Industry: Recognition and Use of a Standard for Uniform Blood and Blood Component Container Labels. Background for the publication was the request of the International Council for Commonality in Blood Banking Automation (ICCBBA) to replace the Version 2.0.0 Standard currently in use for container labels for blood and blood components by the revised Version 3.0.0 Standard. ICCBBA has submitted this revised version in 2013.
The Version 3.0.0 Standard is considerably reorganised and expanded from the Version 2.0.0 Standard. However, there are only limited substantive revisions when compared to the Version 2.0.0 Standard. Specific revisions in the Version 3.0.0 Standard when compared to the Version 2.0.0 Standard include:
Furthermore, note that many more examples of labels and text are included in Version 3.0.0 Standard.
Please also read the complete document for more detailed information.