FDA Issues Revised Reauthorization Of CDC COVID-19 Test, OK’s Change To New York Test
The US agency issued a revised version of an Emergency Use Authorization (EUA) to the Centers for Disease Control and Prevention for the CDC’s COVID-19 test on 15 March, and approved an amendment to New York State’s EUA for its assay on the same day.
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Medtech Insight is tracking the IVD companies manufacturing tests for SARS-CoV-2, the coronavirus that causes COVID-19.
Ready, Set, Go: ‘Unprecedented’ FDA Guidance Aims To Unburden Coronavirus Test Makers, Speed Process
The US agency issued a guidance document that significantly lowers regulation of diagnostics used specifically to fight the ongoing COVID-19 pandemic. The new policies give states far more autonomy, allow diagnostics makers to distribute products before an Emergency Use Authorization is issued by the FDA, and permits certain serological tests on the market if they adhere to proper labeling.
The US FDA on 29 February approved New York State’s and New York City’s combined Emergency Use Authorization request to conduct coronavirus testing at the state’s Wadsworth Center laboratory in Albany, and its NYC public-health department-based lab. Both sites are CLIA-certified to proceed using COVID-19 laboratory-developed tests, the FDA’s Tim Stenzel said during a 2 March webinar on virus testing.