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GUIDANCE DOCUMENT

Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Guidance for Industry September 2016

Final

Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

Docket Number:
FDA-2013-D-1143
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

This guidance provides you, establishments that make donor eligibility (DE) determinations for donors of HCT/Ps, with recommendations for testing living donors for West Nile Virus (WNV) using an FDA-licensed donor screening test. We (FDA) believe that the use of an FDA-licensed nucleic acid test (NAT) will reduce the risk of transmission of WNV from living donors of HCT/Ps and therefore recommend that you use an FDA-licensed NAT to test living donors of HCT/Ps for evidence of infection with WNV as set forth in this guidance. This guidance does not provide information regarding testing of cadaveric HCT/P donors for WNV. This guidance finalizes the draft guidance entitled “Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Draft Guidance for Industry” dated December 2015 (80 FR 77645). This guidance supplements WNV donor screening recommendations in sections IV.E. (recommendations 15 and 16) and IV.F. (recommendation 5), and supersedes the “West Nile Virus (WNV)” section in Appendix 6, of the guidance entitled “Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)” (2007 Donor Eligibility Guidance) dated August 20071 (Ref. 1).


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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-2013-D-1143.

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