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  5. Virtual Town Hall - Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency - 03/06/2020 - 03/06/2020
  1. Workshops & Conferences (Medical Devices)

Town Hall

Event Title
Virtual Town Hall - Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency
March 6, 2020

Date:
March 6, 2020
Time:
1:00 PM - 2:00 PM ET
Organized By:
Organizer

Meeting Materials:

Summary:

On March 6, 2020, the U.S. Food and Drug Administration (FDA) will host a virtual Town Hall for laboratories certified to perform high-complexity testing under the Clinical Laboratory Improvement Amendments (CLIA) that are developing or have developed molecular diagnostic tests for SARS-CoV-2. The purpose of the Town Hall is to help answer technical questions about development and validation of molecular tests for SARS-CoV-2 and the recently-issued guidance.

Background:

On February 29, 2020, the FDA issued the immediately in effect guidance, Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency.

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