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  1. Coronavirus (COVID-19) and Medical Devices

COVID-19 Test Uses: FAQs on Testing for SARS-CoV-2

This page provides answers to frequently asked questions relating to uses for COVID-19 tests (surveillance, screening, and diagnosis).

This section includes questions and answers regarding the policies outlined in the Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff: Policy for Coronavirus Disease-2019 Tests during the Public Health Emergency (Revised). In this section, this guidance is referred to as the Policy for Coronavirus Disease-2019 Tests.

For a directory of FAQs related to SARS-CoV-2 testing, see FAQs on Testing for SARS-CoV-2.

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