Coronavirus (COVID-19) Update
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
The 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.
Reissued the EUA for the Quidel QuickVue At-Home OTC COVID-19 Test to authorize use by people with COVID-19 symptoms as a single test without a health care 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 health care 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 include the following:
Molecular and Antigen Home Use Test Template
Supplemental Template for Molecular and Antigen Diagnostic COVID-19 Tests for Screening with Serial Testing
As of today, 420 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 292 molecular tests and sample collection devices, 90 antibody and other immune response tests and 38 antigen tests. There are 66 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one molecular prescription at-home test, three antigen prescription at-home tests, nine antigen over-the-counter (OTC) at-home tests and two molecular OTC at-home tests.
The FDA has authorized 16 antigen tests and eight molecular tests for serial screening programs. The FDA has also authorized 663 revisions to EUA authorizations.