Today, the U.S. Food and Drug Administration (FDA) posted an updated template intended to assist test developers and facilitate the Emergency Use Authorization (EUA) request and Pre-EUA submission processes for COVID-19 tests. The following template includes updated recommendations and additional clarity for test developers: 

• Molecular and Antigen Home Use Test Template

The template is intended to help test developers provide validation data and other information to the FDA. Developers can use alternative approaches and can discuss them with the FDA. 

Questions? 

If you have questions about the templates, please email COVID19DX@fda.hhs.gov.