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Webinar Materials

• Presentation
• Printable Slides
• Transcript

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:

• 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.

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.

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