Bulletin 24-4

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FDA Determines Zika Virus No Longer an RCDAD, Screening Can Be Suspended and Remain in Regulatory and Standards Compliance

On March 7, 2016, the U.S. Food and Drug Administration (FDA) issued guidance explaining its determination that Zika virus (ZIKV) was a relevant communicable disease agent or disease (RCDAD). This determination was based on the risk of transmission by human cells, tissues, and cellular and tissue-based products (HCT/Ps), severity of effect, availability of appropriate screening measures, and evidence that demonstrated that ZIKV had significant incidence and prevalence to affect the potential HCT/P donor population. 

Since that time, establishments making the final donor-eligibility determination have been required to screen potential donors, both living and deceased, for clinical evidence of ZIKV infection. In addition, living donors were also screened for risk factors for ZIKV infection, as travel to or residence in countries considered to be at high risk for ZIKV served as exclusionary criteria. This requirement was also reflected in AATB Standards Appendix II and donor risk assessment interview forms (DRAIs).

On May 20, 2024, the FDA announced that ZIKV “is no longer an RCDAD under FDA’s regulations because…the available evidence demonstrates that ZIKV no longer has sufficient incidence and/or prevalence to affect the potential HCT/P donor population.” The guidance titled, “Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus by HCT/Ps,” dated May 2018, has been withdrawn. Per FDA, “HCT/P establishments may discontinue screening donors for ZIKV.”

Accordingly, AATB is in the process of removing ZIKV-related screening criteria from its Standards and DRAIs. As of May 20, 2024, accredited tissue banks may stop screening for ZIKV as part of donor eligibility determinations. AATB will be exercising enforcement discretion related to ZIKV screening requirements in Standards until they can be formally revised and published. This will be announced in a subsequent AATB Bulletin.

AATB-accredited banks working directly or indirectly with international tissue establishments, should continue to ensure that country-specific requirements are met, particularly in countries where the public health authorities may continue to require ZIKV screening.

FDA investigators and AATB accreditation inspectors will continue to assess whether the establishment appropriately screened potential living and deceased donors for ZIKV from March 7, 2016, to May 20, 2024.

If you have questions, please contact accreditation@aatb.org.