Coronavirus (COVID-19) Update: FDA Provides Promised Transparency for Antibody Tests

Today, the U.S. Food and Drug Administration 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.

On May 21, 2020, the U.S. Food and Drug Administration 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 Antibody tests on this removal list include both those voluntarily withdrawn by the test’s commercial manufacturer and those for which there is not a pending or issued Emergency Use Authorization request. FDA Commissioner Stephen M. Hahn, M.D. called the action “an important step the agency has taken to ensure that Americans have access to trustworthy tests.”