FDA Issues EUA for Avian Influenza A(H7N9) Diagnostic Device

Summary

The US Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for an in vitro diagnostic device to detect the novel Avian Influenza A(H7N9) virus, following a determination by the Secretary of Health and Human Services that there is a significant public health emergency risk. This authorization allows for the emergency use of the device subject to specific conditions.