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GUIDANCE DOCUMENT

Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components Guidance for Industry July 2018

Final
Docket Number:
FDA-2016-D-0545
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

We, FDA, are providing you, blood establishments that collect Whole Blood and blood components, with revised recommendations to reduce the risk of transmission of Zika virus (ZIKV) by Whole Blood and blood components. In August 2016, FDA recognized ZIKV as a relevant transfusion-transmitted infection (RTTI) under Title 21 of the Code of Federal Regulations (CFR) Part 630. The recommendations contained in this guidance apply to the collection of Whole Blood and blood components. This guidance does not apply to the collection of Source Plasma.


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:

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-2016-D-0545.

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