FDA Updates COVID-19 Test Policies 

Today, the U.S. Food and Drug Administration is taking several important actions intended to support ongoing nationwide COVID-19 testing efforts. These actions are aimed at further increasing access to accurate and reliable tests, particularly COVID-19 diagnostic tests that can be performed at home or in places like doctor’s offices, hospitals, urgent care centers, and emergency rooms without having to be sent to a central lab for testing.

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The FDA:

• Reissued the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised).
• Issued a new Umbrella EUA for SARS-CoV-2 Molecular Diagnostic Tests developed by laboratories for Serial Testing.
• Reissued the EUA for Molecular Diagnostic Tests for SARS-CoV-2 Developed And Performed By Laboratories Certified Under CLIA To Perform High Complexity Tests.
• Revised the Enforcement Policy for Viral Transport Media During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency to update references to the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency.
• Updated the FAQs on Testing for SARS-CoV-2.

Questions?

If you have questions, please email COVID19DX@fda.hhs.gov