FAQs on Testing for SARS-CoV-2
March 24, 2023 - The FDA has finalized two guidances: Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency and Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19). The guidances outline the FDA's general recommendations to transition from certain policies adopted and operations implemented during the COVID-19 pandemic to normal operations, including the FDA's recommendations for:
- Developing a transition implementation plan,
- Submitting a marketing submission, and
- Taking other actions with respect to these devices.
The FDA encourages stakeholders to review the two final guidances, attend the webinar, and reach out to the FDA if they have questions or concerns. In particular, for manufacturers planning to seek marketing authorization for their devices, the FDA recommends beginning work on a marketing submission, including a transition implementation plan, as described in the guidances.
- 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 - April 18, 2023
This section is primarily 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
- Testing Supplies
- COVID-19 Related Test Data and Reporting
COVID-19 Resources for Test Developers
- 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: 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.
- EUA Authorized Serology 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
- 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.