On Wednesday, March 25, 2020 (3–4 p.m. Eastern), 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 SAR-CoV-2.
The purpose of the Town Hall is to help answer technical questions about the development and validation of tests for SARS-CoV-2 and the FDA’s updated policy on COVID-19 Diagnostics issued on March 16, 2020, Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency .
FDA will hold additional virtual town halls on the following dates:
- April 1, 2020
- April 8, 2020
- April 15, 2020
- April 22, 2020
- April 29, 2020
- May 13, 2020
- May 20, 2020
- May 27, 2020
All meetings are scheduled for 1:15–2:15 p.m. Eastern.
The guidance is designed to provide a policy to help accelerate the availability of novel coronavirus (COVID-19) diagnostic tests developed during the public health emergency in order to achieve more rapid and widespread testing capacity in the United States.