FDA Determines that Zika Virus is No Longer a Relevant Communicable Disease Agent or Disease

May 21, 2024

On Monday, May 20, 2024, the FDA announced the release of “Information for Human Cell, Tissue, and Cellular and Tissue-Based Product (HCT/P) Establishments Regarding FDA’s Determination that Zika Virus is no Longer a Relevant Communicable Disease Agent or Disease” (RCDAD). This update includes the withdrawal of the 2018 guidance titled, “Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products.” This announcement explains that Zika virus (ZIKV) is no longer an RCDAD.

The FDA's decision means that HCT/P establishments are no longer required to screen potential donors for ZIKV and should revise their procedures accordingly. This change follows advocacy from AATB and accredited birth tissue establishments and staff who have supported the elimination of ZIKV screening for HCT/P donors.

In 2016, the FDA had determined ZIKV as an RCDAD due to its risk of transmission by HCT/Ps, severity of effect, the availability of appropriate screening measures, and the available evidence that demonstrated, at the time, that ZIKV had significant incidence and prevalence to affect the potential HCT/P donor population. However, recent evidence shows that ZIKV no longer has sufficient incidence and/or prevalence to impact the potential donor population. Currently, the CDC does not identify any countries or territories with ZIKV outbreaks on their world map travel advisory. The FDA will continue to monitor ZIKV epidemiology and may reclassify it as an RCDAD if necessary in the future.