https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas?utm_campaign=2020-07-02%20COVID-19%20Update%3A%20FDA%20Takes%20Steps%20to%20Streamline%20Development%20of%20Combo%20Tests&utm_medium=email&utm_source=Eloqua

COVID-19 Update: FDA Takes Steps to Streamline Development of Combination Tests for Detection and Differentiation of the Viruses that Cause Flu and COVID-19

Today, the U.S. Food and Drug Administration (FDA) updated the Molecular Diagnostic templates on FDA.gov that may be used to facilitate submission of requests for emergency use authorization (EUA) to further encourage development of combination tests for detection and differentiation of SARS-CoV-2 as well as other respiratory organisms such as the viruses that cause flu. In particular, the Molecular Diagnostic templates include recommendations for laboratories and commercial manufacturers who may choose to use the templates to help facilitate the preparation and submission of an EUA request for combination tests that may be useful in preserving critical testing resources during the upcoming flu season.

Read More Questions? Email CDRH-EUA-Templates@fda.hhs.gov.