On May 21, 2020, the U.S. Food and Drug Administration (FDA) posted list of antibody tests removed from the ‘notification list’ of tests being offered during the public health emergency. Tests on the removal list are prohibited from being marketed or distributed or offered by commercial manufacturers.

Antibody tests on this new removal list include those voluntarily withdrawn from the notification list by the test’s commercial manufacturer and those for which there is not a pending Emergency Use Authorization (EUA) request or issued EUA.

The FDA expects that the tests on the removal list will not be marketed or distributed. Antibody tests offered by commercial manufacturers as outlined under the policy, which was issued on March 16 and updated on May 4, continue to be located on the notification list pending review of their EUA request.