![]() 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 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 FDA encourages developers to discuss any alternative technological approaches to validating their test with the FDA through of the public can submit questions about the templates to or they can submit comments regarding the templates to the public docket established for the guidance Policy for Coronavirus Disease-2019 Tests (Revised). 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.ĭevelopers who intend to use alternative approaches should consider seeking the FDA's feedback or recommendations to help them through the EUA process. The templates reflect the FDA's current thinking on the data and information that developers should submit to facilitate the EUA process. These templates are part of the Policy for Coronavirus Disease-2019 Tests (Revised), which also includes additional policies specific to this public health emergency. Template for Serology Tests that Detect or Correlate to Neutralizing Antibodies (October 6, 2021).Supplemental Template for Molecular and Antigen Diagnostic COVID-19 Tests for Screening with Serial Testing (October 25, 2021).Molecular and Antigen Home Use Test Template (November 9, 2021).Antigen Diagnostic Template (October 6, 2021).Molecular Diagnostic Home Specimen Collection Template (October 6, 2021).Molecular Diagnostic Template (October 6, 2021).Molecular Diagnostic EUA Cover Sheet Template (October 6, 2021). ![]() ![]() 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) IVDs for Management of COVID-19 Patients.Individual EUAs for Serology and Other Adaptive Immune Response Tests for SARS-CoV-2.Serology and Other Adaptive Immune Response Tests for SARS-CoV-2.Individual EUAs for Genotyping Tests for SARS-CoV-2.Individual EUAs for Diagnostic Breath Tests for SARS-CoV-2.Antigen EUA Revision for Serial (Repeat) Testing.Individual EUAs for Antigen Diagnostic Tests for SARS-CoV-2.Antigen Diagnostic Tests for SARS-CoV-2.EUA for Molecular Diagnostic Tests for SARS-CoV-2 Developed And Performed By Laboratories Certified Under CLIA To Perform High Complexity Tests.Umbrella EUA for SARS-CoV-2 Molecular Diagnostic Tests for Serial Testing.Pooling and Serial Testing Amendment for Certain Molecular Diagnostic Tests for SARS-CoV-2.Individual EUAs for Molecular Diagnostic Tests for SARS-CoV-2.Molecular Diagnostic Tests for SARS-CoV-2.The web pages below include tables of SARS-CoV-2 and COVID-19 related IVDs with emergency use authorizations (EUAs). Tables of IVD Emergency Use Authorizations: Once patients are diagnosed with COVID-19 disease, these additional tests can be used to inform patient management decisions. 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.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.These include molecular tests, such as nucleic acid amplification tests, and antigen tests, as well as diagnostic tests that analyze breath samples. Diagnostic Tests: Tests that can be used to diagnose infection with the SARS-CoV-2 virus.There are several types of SARS-CoV-2 and COVID-19 related IVDs: 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. 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.
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