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Regulatory Focus™ > News Articles > 2020 > 5 > FDA names companies removed from antibody test list

FDA names companies removed from antibody test list

Posted 21 May 2020 | By Michael Mezher 

FDA names companies removed from antibody test list

After tightening its oversight of antibody tests for coronavirus disease (COVID-19) earlier this month, the US Food and Drug Administration (FDA) on Thursday began publicly listing commercial manufacturers that have either failed to submit an emergency use authorization (EUA) request or voluntarily withdrew notification for their antibody tests distributed under the agency’s former policy.
 
In its initial policy in March, FDA said it would not object to the development and use of antibody tests by laboratories or commercial manufacturers without FDA review or authorization so long as the tests were validated and the agency had been notified before a company marketed its test.
 
Following reports questioning the accuracy of some of the antibody tests on the market, FDA revised its policy in early May to require commercial manufacturers to submit an EUA within 10 business days of the new policy or from when the manufacturer submitted its notification to the agency. (RELATED: FDA tightens oversight of antibody tests for COVID-19, Regulatory Focus 4 May 2020).
 
Now, FDA has updated its frequently asked questions webpage for SARS-CoV-2 tests to include a “removal list” naming commercial manufacturers that had previously notified the agency of their antibody tests but have either failed to submit an EUA request within the required timeframe or voluntarily withdrew their notification.
 
"Our action today is an important step the agency has taken to ensure that Americans have access to trustworthy tests," said FDA Commissioner Stephen Hahn. "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."
 
Currently, the list includes 28 tests made by more than 20 mostly US- or China-based companies that have been removed from the agency’s notification list. Eleven of the 28 test notifications have been withdrawn voluntarily by their manufacturers.
 
FDA says it expects that tests added to the removal list will no longer be distributed "unless and until" an EUA is granted, meaning tests placed on the removal list may no longer be distributed based on notification.
 
FDA

Editor's note: This article has been updated to clarify FDA's expectations for tests added to the removal list and to note the addition of one test to the removal list since initial publication.

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