FDA requires blood establishments to test blood donations for new or emerging infectious agents that may affect blood product safety if certain conditions outlined in FDA regulations are met. Specifically, if a transfusion-transmitted infection “may have sufficient incidence and/or prevalence to affect the potential donor population” and meets certain other criteria described in FDA’s regulations, then FDA may determine the transfusion-transmitted infection is a “relevant transfusion-transmitted infection” (RTTI). Testing for an RTTI is required under FDA’s regulations if FDA-licensed, approved, or cleared screening tests are available and testing is necessary to reduce adequately and appropriately the risk of transmission.
FDA has determined Zika virus (ZIKV) is no longer an RTTI under FDA’s regulations because, as discussed further below, the available evidence demonstrates that ZIKV no longer has sufficient incidence and/or prevalence to affect the potential donor population. Accordingly, FDA withdrew the guidance titled, “Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components,” dated July 2018. Because ZIKV is no longer an RTTI, blood establishments may discontinue testing for ZIKV. Licensed blood establishments that discontinue testing blood donations for ZIKV must report this change to FDA in the annual report under 21 CFR 601.12(d), noting the date testing was discontinued. Corresponding changes to the circular of information must also be reported in the annual report under 21 CFR 601.12(d).