On March 16, 2020, the FDA published notice for “Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency.” This document supersedes “Policy for Diagnostics Testing in Laboratories Certified to Perform High-Complexity Testing under Clinical Laboratory Improvement Amendments (CLIA) prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency” issued February 29, 2020.

Click here to access the document.

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