GUIDANCE DOCUMENT
Recognition and Use of a Standard for Uniform Blood and Blood Component Container Labels Guidance for Industry June 2014
- Docket Number:
- FDA-1998-D-0067
- Issued by:
-
Guidance Issuing OfficeCenter for Biologics Evaluation and Research
We, FDA, Center for Biologics Evaluation and Research (CBER), are recognizing as acceptable for use by you, manufacturers of blood and blood components, subject to United States statutes and regulations, the document entitled United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128, Version 3.0.0, dated March 2013 (Version 3.0.0 Standard). The Version 3.0.0 Standard is the revised version of the United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128, Version 2.0.0, dated November 2005 (the Version 2.0.0 Standard).
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Dockets Management
Food and Drug Administration
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All written comments should be identified with this document's docket number: FDA-1998-D-0067.