Virtual Town Hall Series - Coronavirus Test Development and Validation

On October 28, 2020, from 12:15 pm - 1:15 pm Eastern Time, the U.S. Food and Drug Administration (FDA) will host a virtual Town Hall for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for SARS-CoV-2. The purpose of this Town Hall is to help answer technical questions about the development and validation of tests for SARS-CoV-2.

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The FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. The FDA is committed to providing timely guidance to support response efforts to this pandemic.

The immediately in effect guidance "Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)" includes policies specific to this public health emergency. This guidance was issued on February 29, 2020 and subsequently updated on March 16, 2020, May 4, 2020, and May 11, 2020.