Have COVID-19 tests been approved by the Food and Drug Administration (FDA)?

The antibody tests and the molecular tests (together referred to as “tests”) have not been cleared or approved by the Food and Drug Administration (FDA);

The FDA has authorized the use of some tests by certain laboratories under Emergency Use Authorization (EUA);  

The antibody tests have been authorized for the detection of antibodies against SARS-CoV-2 only, and not for the detection of any other viruses or pathogens;

The molecular (PCR) tests have been authorized for the detection of nucleic acid from SARS-CoV-2 only, and not for the detection of any other viruses or pathogens; and    

Tests are only authorized for as long as the circumstances exist to justify the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.