The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
- On Monday November 15, 2021 the FDA took several important actions intended to support ongoing nationwide COVID-19 testing efforts. These actions are aimed at further increasing access to accurate and reliable tests, particularly COVID-19 diagnostic tests that can be performed at home or in places like doctor’s offices, hospitals, urgent care centers, and emergency rooms without having to be sent to a central lab for testing.
The FDA:- Reissued the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised).
- Issued a new Umbrella EUA for SARS-CoV-2 Molecular Diagnostic Tests developed by laboratories for Serial Testing.
- Reissued the EUA for Molecular Diagnostic Tests for SARS-CoV-2 Developed And Performed By Laboratories Certified Under CLIA To Perform High Complexity Tests.
- Revised the Enforcement Policy for Viral Transport Media During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised) to update references to the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency.
- Updated the FAQs on Testing for SARS-CoV-2.
- Testing updates:
- As of today, 422 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 293 molecular tests and sample collection devices, 90 antibody and other immune response tests and 39 antigen tests. There are 66 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one EUA for a molecular prescription at-home test, three EUAs for antigen prescription at-home tests, 10 EUAs for antigen over-the-counter (OTC) at-home tests and three EUAs for molecular OTC at-home tests.
- The FDA has authorized 19 antigen tests and nine molecular tests for serial screening programs. The FDA has also authorized 685 revisions to test EUA authorizations.
