13/14 December 2022
As reported before, the Food and Drug Administration's Center for Biologics Evaluation and Research (FDA CBER) published a new guidance document entitled "Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products." Related to the current situation with this virus, the FDA is issuing this guidance for immediate implementation in accordance with 21 CFR 10.115(g)(2) on 1 March.
This was follwed by documents on their Guidance on donor screening and deferral concerning the risk of ZIKA virus transmission and related to some non-travel related cases of Zika virus the "Advice to Blood Collection Establishments on Non-Travel Related Cases of Zika Virus in Florida".
Now, for immediate implementation, the FDA published the "Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components". In their introduction, the FDA states:
"This guidance document supersedes the guidance document entitled, “Recommendations for Donor Screening, Deferral, and Product Management to Reduce the Risk of Transfusion-Transmission of Zika Virus; Guidance for Industry,” (dated February 2016) and the guidance document entitled, “Questions and Answers Regarding “Recommendations for Donor Screening, Deferral, and Product Management to Reduce the Risk of Transfusion-Transmission of Zika Virus; Guidance for Industry,” (dated March 2016) no later than 12 weeks after the date of the issuance of this guidance. Implementation of the guidance will be immediate for blood establishments that collect Whole Blood and blood components in states and territories with local transmission of Zika virus by mosquitos, and will be phased in over 4 to12 weeks in other states and territories using a tiered, risk-based approach. Blood establishments should follow the recommendations in the February 2016 guidance until the recommendations in this guidance document have been fully implemented. See section V. of this guidance for further recommendations on implementation."
Please read more details about the background as well as the products the guidance apply to in the "Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components"