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GUIDANCE DOCUMENT

Recognition and Use of a Standard for Uniform Blood and Blood Component Container Labels Guidance for Industry June 2014

Download the Final Guidance Document
Final Level 2 Guidance
Docket Number:
FDA-1998-D-0067
Issued by:
Guidance Issuing Office
Center 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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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-1998-D-0067.

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