Bulletin 18-5

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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:

  1. Providing findings from more recent epidemiological studies including impact on public health;
  2. Reporting new data that informs the potential for transmission of ZIKV;
  3. Discussing the current status of availability of ZIKV tests;
  4. Updating sexual contact risk factors;
  5. Updating the criteria for considering an area to have an increased risk for ZIKV transmission; and
  6. 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.