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Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (see List 1) are no longer in effect.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?
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, view 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
In vitro diagnostic (IVD) devices are tests performed on samples taken from the human body, such as swabs of mucus from inside the nose or back of the throat, or blood taken from a vein or fingerstick. IVDs can detect diseases or other conditions and can be used to monitor a person's overall health to help cure, treat, or prevent diseases.
There are several types of SARS-CoV-2 and COVID-19 related IVDs:
- Diagnostic Tests: Tests that can be used to diagnose infection with the SARS-CoV-2 virus. These include molecular tests, such as nucleic acid amplification tests, and antigen tests, as well as diagnostic tests that analyze breath samples.
- Serology/Antibody and Other Adaptive Immune Response Tests: Tests that detect antibodies (for example, IgM, IgG) to the SARS-CoV-2 virus or that measure a different adaptive immune response (such as, T cell immune response) to the SARS-CoV-2 virus. These types of tests cannot be used to diagnose a current infection.
- Tests for Management of COVID-19 Patients: Beyond tests that diagnose or detect SARS-CoV-2 virus or antibodies, there are also tests that are authorized for use in the management of patients with COVID-19, such as to detect biomarkers related to inflammation. Once patients are diagnosed with COVID-19 disease, these additional tests can be used to inform patient management decisions.
Since the Secretary’s declaration under section 564 of the Federal Food, Drug, and Cosmetic Act related to in vitro diagnostic tests for COVID-19, on February 4, 2020, the FDA has granted EUAs for many COVID-19 tests, based on a determination that they met the statutory criteria for EUA. EUA-authorized tests can continue to be used as long as they are available and not expired and the EUA has not been revoked. This page provides information about these EUAs.
The FDA has been working with COVID-19 test developers seeking to pursue marketing authorization through the traditional premarket review pathways, which will allow these tests to continue to be used beyond the time allowed by emergency use authorization. See COVID-19 Tests Granted Traditional Marketing Authorization by the FDA for additional information on COVID-19 tests that have received traditional marketing authorizations, as well as information about the traditional premarket review and authorization process.
Tables of IVD Emergency Use Authorizations:
The web pages below include tables of SARS-CoV-2 and COVID-19 related IVDs with emergency use authorizations (EUAs).
- Molecular Diagnostic Tests for SARS-CoV-2
- Individual EUAs for Molecular Diagnostic Tests for SARS-CoV-2
- Revision Concerning Viral Mutation
- Pooling and Serial Testing Amendment for Certain Molecular Diagnostic Tests for SARS-CoV-2
- Umbrella EUA for SARS-CoV-2 Molecular Diagnostic Tests for Serial Testing
- EUA for Molecular Diagnostic Tests for SARS-CoV-2 Developed And Performed By Laboratories Certified Under CLIA To Perform High Complexity Tests
- Antigen Diagnostic Tests for SARS-CoV-2
- Other Tests for SARS-CoV-2
- Individual EUAs for Diagnostic Breath Tests for SARS-CoV-2
- Individual EUAs for Genotyping Tests for SARS-CoV-2
- Serology and Other Adaptive Immune Response Tests for SARS-CoV-2
- IVDs for Management of COVID-19 Patients
Templates for EUA submissions for several types of COVID-19 tests are available to help facilitate the preparation, submission, and authorization of an EUA request:
Diagnostic Templates (Molecular and Antigen)
- Molecular Diagnostic EUA Cover Sheet Template (October 6, 2021)
- Molecular Diagnostic Template (October 6, 2021)
- Molecular Diagnostic Home Specimen Collection Template (October 6, 2021)
- Antigen Diagnostic Template (October 6, 2021)
- Molecular and Antigen Home Use Test Template (November 9, 2021)
- Supplemental Template for Molecular and Antigen Diagnostic COVID-19 Tests for Screening with Serial Testing (October 25, 2021)
- Serology Template (October 6, 2021)
- Template for Serology Tests that Detect or Correlate to Neutralizing Antibodies (October 6, 2021)
These templates are part of the Policy for Coronavirus Disease-2019 Tests (Revised), which also includes additional policies specific to this public health emergency. The templates reflect the FDA's current thinking on the data and information that developers should submit to facilitate the EUA process. The templates provide information and recommendations, and we plan to update them as appropriate as we learn more about the COVID-19 disease and gain experience with the EUA process for the various types of COVID-19 tests.
Developers who intend to use alternative approaches should consider seeking the FDA's feedback or recommendations to help them through the EUA process. The FDA encourages developers to discuss any alternative technological approaches to validating their test with the FDA through CDRH-EUA-Templates@fda.hhs.gov.
Members of the public can submit questions about the templates to CDRH-EUA-Templates@fda.hhs.gov, or they can submit comments regarding the templates to the public docket established for the guidance Policy for Coronavirus Disease-2019 Tests (Revised).
Test developers interested in pursuing an EUA may submit a pre-EUA to begin discussions with the FDA or may submit an EUA request to CDRH-EUA-Templates@fda.hhs.gov.
Any test developer requesting an EUA that intends to leverage data from another developer's EUA-authorized device must obtain a right of reference to leverage the performance data for that EUA-authorized device. The Centers for Disease Control and Prevention (CDC) has granted a right of reference to the performance data contained in CDC's EUA request (FDA submission number EUA200001) to any entity seeking an FDA EUA for a COVID-19 diagnostic device.
Additional information can be found on the FAQs on Testing for SARS-CoV-2 page.