FDA Authorizes Emergency Use of In Vitro Diagnostic Device for Zika Virus Diagnosis

Summary

The US Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for an in vitro diagnostic device to diagnose Zika virus infection, in response to the ongoing Zika virus outbreak in the Americas, following a public health emergency determination by the Department of Health and Human Services (HHS) Secretary on February 26, 2016.