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. For general public and consumer FAQs on COVID-19, please see FDA's COVID-19 Frequently Asked Questions.
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), originally issued 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. 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 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 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.
Pages in this section:
- Notifications and Emergency Use Authorizations
- Removal Lists of Tests That Should No Longer Be Used and/or Distributed for COVID-19
- Test Development and Review
- Test Settings
- Test Uses
- Testing Supplies
- 3D Printed Swabs
- COVID-19 Related Test Data and Reporting
- Serology/Antibody Tests
COVID-19 Resources for Test Developers
- Emergency Use Authorizations for Medical Devices: Includes EUAs for In Vitro Diagnostics (e.g., molecular, antigen, and serology tests)
- EUA Authorized Serology Test Performance: Includes summaries of test performance by test and a calculator for test performance.
- Independent Evaluations of COVID-19 Serological Tests
- SARS-CoV-2 Reference Panel Comparative Data
- Pooled Sample Testing and Screening Testing for COVID-19
- FAQs on Viral Transport Media During COVID-19: Includes questions and answers regarding the policies outlined in the Enforcement Policy for Viral Transport Media During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.
- Testing Supply Substitution Strategies: Includes validated supply alternatives that labs can use to continue performing testing when there is a supply issue with some components of a molecular test. Download the slide show file (PPT - 1.5MB) and click Slide Show > From Beginning. (Release date: July 23, 2020)
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 are a health professional, consumer or patient and 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 performing COVID-19 testing should follow the reporting procedures established by their facilities.