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FAQs on Testing for SARS-CoV-2

Author Name, ProPublica

2021-11-13 10:44:00

This section is primarily intended for SARS-CoV-2 test developers. For general public and consumer FAQs on COVID-19, please see FDA's COVID-19 Frequently Asked Questions.

This section provides answers to frequently asked questions relating to the development and performance of tests for SARS-CoV-2. These questions and answers provide additional clarity on existing policies and do not introduce any new policies or modify any existing policies.

This section includes questions and answers regarding the policies described in the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised), originally issued as Policy for Diagnostic Tests in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency on February 29, 2020 and updated on March 16, 2020, May 4, 2020, May 11, 2020, and November 15, 2021. In this section, this guidance is referred to as the Policy for Coronavirus Disease-2019 Tests.

Tests being offered prior to or without an EUA as described in a policy in a previous version or the current version of the Policy for Coronavirus Disease-2019 Tests have not been reviewed or authorized by the FDA. As stated in the current and previous versions of the Policy for Coronavirus Disease-2019 Tests, all such tests should be validated by the developer prior to being offered for clinical use.

Note: Throughout this section and the Policy for Coronavirus Disease-2019 Tests, references to laboratories that are "certified to perform high complexity testing under CLIA" or to "high-complexity CLIA-certified laboratories" are referring to CLIA-certified laboratories that meet the regulatory requirements to perform high-complexity testing.

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[1] URL: https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/removal-lists-tests-should-no-longer-be-used-andor-distributed-covid-19-faqs-testing-sars-cov-2
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