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  1. Emergency Situations (Medical Devices)

FAQs on Diagnostic Testing for SARS-CoV-2

Industry Hotline: Coronavirus COVID-19 Diagnostic Tests and Shortages

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This page provides answers to frequently asked questions relating to the development and performance of diagnostic tests for SARS-CoV-2.

The page includes questions and answers regarding the new policy outlined in the Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff: Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency, originally introduced as Immediately in Effect Guidance for Clinical Laboratories and Food and Drug Administration Staff: 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 29th, 2020 and updated on March 16, 2020. On this page, this guidance is referred to as the Policy for Diagnostic Tests for Coronavirus Disease-2019.

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

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On this page:


What Laboratories and Manufacturers are Offering Tests for COVID-19?


General FAQs


What If I Do Not Have...?


Clinical Laboratory FAQs


Test Kit Manufacturer FAQs


For More Information

If you need additional information for completing the EUA template, would like to know how to submit your Pre-EUA/EUA submission to FDA, or wish to consider use an alternative specimen type, please contact the Division of Microbiology Devices at (301) 348-1778 or email CDRH-EUA-Templates@fda.hhs.gov.


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