NYSDA Publications

FDA Updates OTC COVID-19 Tests

The United States Food and Drug Administration (FDA) has authorized the 10th over-the-counter (OTC) novel coronavirus (COVID-19) test, has reissued the emergency use authorization (EUA) for another OTC COVID-19 test, and has 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 are the:
If you have questions about OTC COVID-19 tests, contact the Division of Industry and Consumer Education.
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