FDA Provides Promised Transparency for Antibody Tests

The U.S. Food and Drug Administration (FDA) posted a list of antibody tests that are being removed from the “notification list” of tests being offered under the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency. Antibody tests on this new removal list include those voluntarily withdrawn from the notification list by the test’s commercial manufacturer and those for which there is not a pending Emergency Use Authorization (EUA) request or issued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. 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.

On May 4, 2020, the FDA announced a revised guidance recommending that commercial manufacturers of antibody tests submit an EUA request within 10 business days from the date they notified FDA of their test validation or the date of publication of the revised policy, whichever was later. In keeping with the FDA’s commitment to transparency, today the agency is providing a list of antibody tests from commercial manufacturers that have been removed from the antibody test notification list. It is expected that this removal list will continue to be updated.

“Our action today is an important step the agency has taken to ensure that Americans have access to trustworthy tests,” said FDA Commissioner Stephen M. Hahn, M.D. “We have seen a high level of collaboration and engagement from developers who want to get this right, and we continue to be available to work extensively with industry to help them with developing accurate tests for the public.”

With this action today, the FDA continues to carry out its mission to protect the public health and safety of consumers. FDA is committed to providing timely information to the American public as part of the agency’s effort to combat this pandemic.