Updated FDA Guidance on Zika Screening Posted
Bulletin 18-5
May 3, 2018
On May 2, 2018, the FDA posted an updated guidance outlining donor screening recommendations aimed at reducing the risk of transmission of Zika Virus by HCT/Ps.
This guidance updates the information published in the March 2016 guidance by:
- Providing findings from more recent epidemiological studies including impact on public health;
- Reporting new data that informs the potential for transmission of ZIKV;
- Discussing the current status of availability of ZIKV tests;
- Updating sexual contact risk factors;
- Updating the criteria for considering an area to have an increased risk for ZIKV transmission; and
- Providing additional scientific references.
This update supports the continuation of recommendations to screen living donors of HCT/Ps for risks of infection with ZIKV based on geographic areas with risk.
FDA recommends that you implement the recommendations in this guidance as soon as feasible, but not later than 4 weeks after the guidance issue date.