June 13, 2024
AABB has developed a toolkit of options for implementation following the Food and Drug Administration’s announcement that the agency no longer considers Zika virus (ZIKV) to be a relevant communicable disease agent or disease (RCDAD) for human cells, tissues and cellular and tissue-based product (HCT/P) donation. As a result, the agency withdrew its May 2018 guidance on screening HCT/P donors for ZIKV infection.
The toolkit outlines options for compliance for facilities that collect hematopoietic progenitor cells (HPCs) until these changes can be incorporated into the next version of the HPC, Apheresis and Marrow Donor History Questionnaire (DHQ) and HPC, Cord Blood DHQ. Because this final guidance removes requirements and does not add requirements, there is flexibility to use less burdensome options and remain in compliance with FDA’s expectations.
AABB intends for the toolkit to help each facility identify flexible options as they consider compliance and implementation strategies that meet the unique needs of their establishment.
Those with questions may contact regulatory@aabb.org.
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