SILVER SPRING, Md. (WAVY) — In an effort to continue giving the public full transparency with COVID-19 testing and information, the FDA posted a list on Friday of antibody tests removed from the “notification list” of tests offered.
“FDA expects that the tests on this list will not be distributed unless and until an EUA [Emergency Use Authorization request] is issued for the test, and FDA may take additional actions as appropriate,” according to the FDA website.
The tests were offered under the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency which issues guidance for accelerating the availability of novel coronavirus tests developed by labs and commercial manufacturers.
The removal list also includes tests that commercial manufacturers voluntarily withdrew from the list for which there is no pending Emergency Use Authorization request or issued EUA.
It is expected that the removal list will continue to be updated.
“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,” said FDA officials in a statement released.
Guidance was released on May 4 specifically outlining that commercial manufacturers of antibody tests submit a EUA request within 10 business days from the date of notifying the FDA of test validation or the date of publication of the revised policy.
“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.”
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