FDA Approves Emergency Use Authorization

On Monday the CDC submitted a request for emergency authorization to the FDA . Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases, said at that time that the approval would significantly expand the US’s ability to test people suspected of having the virus.

The FDA went around the usual processes and regulatory channels and signed off on the test under an Emergency Use Authorization, allowing the use of detection kits and medical products in extreme situations when no FDA approved alternatives are available. The agency previously issued emergency authorizations for tests for Ebola, MERS, and Zika.