The U.S. Food and Drug Administration (FDA) will host a virtual Town Hall for SARS-CoV-2 test developers. The purpose of this Town Hall is to help answer technical questions about the development and validation of tests for SARS-CoV-2.
There will be an opportunity to ask questions live on the call, but questions may also be submitted in advance by emailing [email protected]. Please submit questions by Monday 12pm ET for the virtual town Hall on Wednesday. In the subject line of the email, state “Question for the COVID-19 Test Virtual Town Hall”
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.