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  5. Webinar - 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 - 03/02/2020 - 03/02/2020
  1. Workshops & Conferences (Medical Devices)

Webcast

Event Title
Webinar - 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 2, 2020


Date:
March 2, 2020
Time:
3:00 PM - 4:00 PM ET
Organized By:
Organizer
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Webinar Materials

Summary

On March 2, 2020, the U.S. Food and Drug Administration (FDA) will host a webinar for device manufacturers, industry, and other interested parties to discuss and answer questions about the immediately in effect guidance:

Background

On February 29, 2020, the FDA issued this immediately in effect guidance to provide a policy for novel coronavirus (COVID-19) molecular diagnostics tests developed and used in laboratories certified to perform high-complexity testing under the Clinical Laboratory Improvement Amendments (CLIA) prior to issuance of emergency use authorizations (EUA) for such tests.


Event Materials

Title File Type/Size
COVID-19 Lab Tests Webinar - Slides pdf (68.55 KB)
COVID-19 Lab Tests Webinar - Transcript pdf (93.16 KB)