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GUIDANCE DOCUMENT

Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products Guidance for Industry May 2018

Final
Docket Number:
FDA-2016-D-0768
Issued by:
Guidance Issuing Office
Office of Medical Products and Tobacco, Center for Biologics Evaluation and Research

This guidance provides you, establishments that make donor eligibility (DE) determinations for donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps), with recommendations for screening donors for evidence of, and risk factors for, infection with Zika virus (ZIKV). This guidance updates and supersedes the guidance of the same title dated March 2016 which identified ZIKV as a relevant communicable disease agent or disease (RCDAD) as defined in 21 CFR Part 1271. This guidance also supplements the recommendations contained in the guidance titled “Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)” dated August 2007.


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-0768.

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