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# FDA Guidance on Cell/Tissue Donor Testing
- URL: https://www.fdaweb.com/fda-guidance-on-cell-tissue-donor-testing/
- Published: 2016-09-12T12:00:00.000Z
- Updated: 2026-09-14T21:31:06.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5136783

FDA has posted a [guidance](http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/UCM372084.pdf?ref=fdaweb.com) on “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)” that provides recommendations for testing living donors 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,” the agency says. The guidance supersedes the “West Nile Virus” section in Appendix 6 of the guidance entitled “Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products.”