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Home » Clinical Lab Management » FDA Provides SARS-CoV-2 Test Validation Guidance for High-Complexity Labs Seeking EUA

FDA Provides SARS-CoV-2 Test Validation Guidance for High-Complexity Labs Seeking EUA

Mar 03, 2020
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Madeleine Johnson
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NEW YORK – In response to encouragement from a number of stakeholders, the US Food and Drug Administration has broadened its emergency use authorization process for tests to detect the SARS-CoV-2 virus that causes novel coronavirus disease COVID-19. High-complexity labs are now permitted to develop their own tests.

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