The US Food and Drug Administration (FDA) has published a list of antibody tests that are being removed from the ‘notification list’ of tests to be offered under the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency.
The removal list includes antibody tests voluntarily withdrawn from the notification list by the test’s commercial manufacturer and those that do not have a pending emergency use authorisation (EUA) request or issued EUA.
The FDA also noted that antibody tests offered by commercial manufacturers, outlined under the policy issued on 16 March and updated on 4 May, will remain on the notification list pending review of their EUA request.
The move is expected to protect the public health and safety of consumers. The tests on the removal list are prohibited by the FDA from marketing or distribution.
FDA Commissioner Stephen Hahn said: “Our action today is an important step the agency has taken to ensure that Americans have access to trustworthy tests.
“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.”
Earlier this month, the agency updated revised guidance, recommending that commercial manufacturers of antibody tests submit a EUA request within ten business days from the date they notified FDA of their test validation or the date of publication of the revised policy.
As part of the effort to combat the Covid-19 pandemic, the agency will continue to provide timely information to the American public.