FDA authorizes additional COVID-19 over-the-counter antigen tests and provides updated EUA templates
The U.S. Food and Drug Administration (FDA) authorized the 10th over-the-counter (OTC) COVID-19 test, reissued the emergency use authorization (EUA) for another OTC COVID-19 test, and updated the EUA templates for test developers seeking an EUA for OTC tests.
The FDA issued an EUA for the Celltrion Diatrust COVID-19 Ag Home Test, an OTC COVID-19 diagnostic antigen test. The test can be used by people with COVID-19 symptoms as a single test without a health care provider prescription, or by people with or without symptoms for serial testing, which means the test is performed two times over three days.
The reissued EUA for the Quidel QuickVue At-Home OTC COVID-19 Test authorizes use by people with COVID-19 symptoms as a single test without a healthcare provider prescription. The test is already authorized for use by people with or without symptoms as a serial test and for people with COVID-19 symptoms as a single test with a healthcare provider prescription.
Updated the test labeling recommendations for test instructions and product labeling in the EUA templates for test developers to support authorization of more COVID-19 tests for use without a health care provider prescription. The updated templates also include flexible study recommendations about how to demonstrate that different types and ages of consumers can use the test appropriately. These updated templates are the:
- Molecular and Antigen Home Use Test Template
- Supplemental Template for Molecular and Antigen Diagnostic COVID-19 Tests for Screening with Serial Testing
FDA releases:
