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  1. Coronavirus (COVID-19) and Medical Devices

FAQs on Testing for SARS-CoV-2

COVID-19 Resources for Laboratories and Manufacturers

Reporting Problems to the FDA

The sale of fraudulent COVID-19 products is a threat to the public health. Consumers and health care professionals can help by reporting suspected fraud to the FDA's Health Fraud Program or the Office of Criminal Investigations. You can also email FDA-COVID-19-Fraudulent-Products@fda.hhs.gov.

If you think you had a problem with your diagnostic test, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.

Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

This page 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. For general public and consumer FAQs on testing, please see FDA's COVID-19 Frequently Asked Questions.

The page 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), 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 29, 2020 and updated on March 16, 2020, May 4, 2020, and May 11, 2020. On this page, this guidance is referred to as the Policy for Coronavirus Disease-2019 Tests.

Tests being offered prior to or without an EUA under a policy outlined in the Policy for Coronavirus Disease-2019 Tests, have not been reviewed or authorized by the FDA. As stated in 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 page 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.

Get Updates: In Vitro Diagnostics

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On this page:

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

What Tests Should No Longer Be Used and/or Distributed for COVID-19?

General FAQs

Testing Supply FAQs

3D Printed Swab FAQs

Test Validation FAQs

COVID-19 Related Test Data and Reporting FAQs

Clinical Laboratory Diagnostic Test FAQs

Test Kit Manufacturer Diagnostic Test FAQs

Serology/Antibody Test FAQs

For More Information

If you need additional information for completing an EUA template, would like to know how to submit your Pre-EUA/EUA submission to FDA, or wish to consider use of alternative approaches to validating your test, please email CDRH-EUA-Templates@fda.hhs.gov.

Virtual Town Hall Meeting Materials

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