FDA Updates COVID-19 Testing Guidances

The U.S. Food & Drug Administration (FDA) issued two new versions of guidance documents for COVID-19 tests on January 12, 2023: Policy for Coronavirus Disease-2019 Tests (the “COVID-19 Test Guidance”) and Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests (the “Viral Mutations Guidance”). The COVID-19 Test Guidance supersedes its last version issued on September 27, 2022, and the Viral Mutations Guidance supersedes its first version issued on February 22, 2021. FDA issued these guidance documents the day after the U.S. Department of Health & Human Services (HHS) Secretary most recently renewed the section 319 Public Health Emergency declaration for COVID-19 (the “PHE declaration”) on January 11, 2023. The PHE declaration will expire in April 2023 unless the HHS Secretary terminates it earlier or renews it for another 90 days.
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