Reminder: Virtual Town Hall for the Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests

On Wednesday, March 25, 2020, from 3 pm - 4pm 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 SAR-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 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.

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SAVE THE DATE: The FDA also plans to hold virtual town halls for clinical laboratories and commercial manufacturers to help answer questions on the following dates: April 1, 2020 from 3:00 pm – 4:00 pm Eastern Time April 8, 2020 from 3:00 pm – 4:00 pm Eastern Time April 15, 2020 from 3:00 pm – 4:00 pm Eastern Time April 22, 2020 from 3:00 pm – 4:00 pm Eastern Time April 29, 2020 from 3:00 pm – 4:00 pm Eastern Time Questions? For general questions, including about this Town Hall, contact Division of Industry and Consumer Education. For specific questions about COVID-19 diagnostic development, contact CDRH-EUA-Templates@fda.hhs.gov.