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 detect parts of the SARS-CoV-2 virus and can be used to diagnose infection with the SARS-CoV-2 virus. These include molecular tests and antigen tests.
- 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.
Any test developer requesting an EUA that intends to leverage data from another 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.
Templates for these EUA submissions are available to help facilitate the preparation, submission, and authorization of an EUA:
Diagnostic Templates (Molecular and Antigen)
- Molecular Diagnostic Template for Commercial Manufacturers (updated July 28, 2020)
- Molecular Diagnostic Template for Laboratories (updated July 28, 2020)
- Home Specimen Collection Molecular Diagnostic Template (May 29, 2020)
- Antigen Template for Test Developers (October 26, 2020)
- Template for Manufacturers of Molecular and Antigen Diagnostic COVID-19 Tests for Non-Laboratory Use (July 29, 2020)
- Supplemental Template for Developers of Molecular and Antigen Diagnostic COVID-19 Tests for Screening with Serial Testing (March 16, 2021)
- Serology Template for Test Developers (March 17, 2021)
- Template for Test Developers of Serology Tests that Detect or Correlate to Neutralizing Antibodies (March 17, 2021)
- Home Specimen Collection Serology Template for Fingerstick Dried Blood Spot (November 24, 2020)
These templates are part of the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised) - Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff, 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) - Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff.
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.
Additional information can be found on the FAQs on Testing for SARS-CoV-2 page.
Tables of IVD EUAs:
- Molecular Diagnostic Tests for SARS-CoV-2
- Antigen Diagnostic Tests for SARS-CoV-2
- Serology and Other Adaptive Immune Response Tests for SARS-CoV-2
- IVDs for Management of COVID-19 Patients
- Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised) Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff
- Insight into FDA's Revised Policy on Antibody Tests: Prioritizing Access and Accuracy
- FAQs on Testing for SARS-CoV-2