November 8, 2023- The COVID-19 public health emergency (PHE) declared under section 319 of the Public Health Service (PHS) Act expired on May 11, 2023. The COVID-19 enforcement policy guidances within scope of the Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (see List 1) are no longer in effect.
The end of the COVID-19 PHE and certain COVID-19 enforcement policy guidances no longer being in effect do not impact the FDA's ability to authorize devices, including tests, for emergency use. Existing emergency use authorizations (EUAs) for devices relating to COVID-19 remain in effect under section 564 of the Federal Food, Drug, and Cosmetic Act. The FDA encourages manufacturers of devices issued EUAs related to COVID-19 to review the guidance: Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19) and Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19), which outlines the FDA's recommendations and expectations to such manufacturers to transition to normal operations when the declarations that allowed for FDA to issue EUAs under section 564 of the Federal Food, Drug, and Cosmetic Act end. Additional information is provided on the page FAQs: What happens to EUAs when a public health emergency ends?
This section is intended for SARS-CoV-2 test developers and provides answers to frequently asked questions (FAQs) about the development and performance of tests for SARS-CoV-2.
For answers to frequently asked questions about at-home COVID-19 diagnostic tests visit At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions.
The questions and answers in this section are about the policies described in the Policy for Coronavirus Disease-2019 Tests (Revised). This guidance is commonly referred to as the Policy for Coronavirus Disease-2019 Tests. These questions and answers provide additional clarity on existing policies and do not introduce any new policies or modify any existing policies.
As described in the September 2022 version of the Policy for Coronavirus Disease-2019 Tests, the FDA:
- Generally expects COVID-19 tests to have been issued an Emergency Use Authorization (EUA) or marketing authorization [PMA, De Novo, 510(k)] prior to the tests being distributed or offered; and
- Intends to focus its review of EUA requests on COVID-19 diagnostic tests that are likely to have a significant public health benefit or are likely to fulfill an unmet need. This could include novel technologies like the use of breath samples, or unique features like the ability of a test to detect a new SARS-CoV-2 virus variant.
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 a single CLIA-certified laboratory that meets the regulatory requirements to perform high-complexity testing.
Pages in this section:
- Notifications and Emergency Use Authorizations
- At-Home COVID-19 Diagnostic Tests
- Test Development and Review
- Test Uses
- COVID-19 Related Test Data and Reporting
COVID-19 Resources for Test Developers
- Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
- Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19)
- Webinar on Guidances on COVID-19 Transition Plans for Medical Devices - 04/18/2023
- Emergency Use Authorizations for Medical Devices: Includes EUAs for In Vitro Diagnostics (for example, molecular, antigen, and serology tests)
- Coronavirus (COVID-19) and Medical Devices: In Vitro Diagnostic Tests
- SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests
- FAQs on Viral Transport Media During COVID-19
- EUA Authorized Serology Test Performance
- Independent Evaluations of COVID-19 Serological Tests
- Pooled Sample Testing and Screening Testing for COVID-19
- Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation
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.