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.
Tables of IVD 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 During the Public Health Emergency (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 During the Public Health Emergency (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.