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, 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.