What are the FDA guidelines for reducing the risk of transmission of Zika virus via blood products?

Updated: Jun 30, 2021
  • Author: Bhagyashri D Navalkele, MD, MBBS; Chief Editor: Michael Stuart Bronze, MD  more...
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Answer

Virus Transmission by Blood and Blood Components 

On May 12, 2021, the US Food and Drug Administration (FDA) stopped recommending that blood establishments test donated blood for Zika virus (ZIKV). The FDA withdrew its July 2018 guidance titled, “Revised Recommendations for Reducing the Risk of Zika,” after it determined that ZIKV is not a “relevant transfusion-transmitted infection” (RTTI) because it “no longer has sufficient incidence and/or prevalence to affect the potential donor population.” [45]

Licensed blood establishments that stop testing donated blood for ZIKV are required to report this change, the date testing ended, and “corresponding changes to the circular of information” to the FDA in the yearly report under 21 DFR 601.12(d). [45]


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