U.S. flag An official website of the United States government
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Recognition and Use of a Standard for Uniform Blood and Blood Component Container Labels
  1. Regulatory Information

GUIDANCE DOCUMENT

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

Final Level 2 Guidance

Recognition and Use of a Standard for Uniform Blood and Blood Component Container Labels

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).


Submit Comments

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:

Division of Dockets Management (HFA- 305)
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.

Questions?

Contact Point
Office of Communication, Outreach and Development (OCOD)
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3128
Silver Spring, MD 20993-0002
ocod@fda.hhs.gov
(800) 835-4709
(240) 402-8010