An official website of the United States government Here’s how you know

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

In this section: Search for FDA Guidance Documents

GUIDANCE DOCUMENT

United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128 June 2014

Final

Docket Number:: 98D-0965
Issued by:: Guidance Issuing Office

Center for Biologics Evaluation and Research

The purpose of this document is to provide guidance on labeling requirements in the US for blood and blood components.

Submit Comments

Submit Comments Online

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: 98D-0965.

Questions?

Top