Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency
U.S. Food and Drug Administration. (2020). Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency.
This resource provides an overview of the “Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff,” allowing for the acceleration of COVID-19 diagnostic tests developed by commercial manufacturers and laboratories.
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