NEW YORK – The US Food and Drug Administration has removed 27 tests from the list of SARS-CoV-2 serology assays that notified under its Policy D that it intended to seek Emergency Use Authorization. The makers of the tests either voluntarily withdrew them or the firms failed to submit the necessary validation data by a recently issued deadline.
The 27 serology tests now listed on the FDA's website as removed from the notification list include nine that were voluntarily withdrawn. The serology test kits were allowed to be distributed in the US under Policy D now number 187, according to the agency.
The FDA had previously allowed SARS-CoV-2 antibody test developers to follow a pathway that simply required notification in an email — as well as providing cursory validation data and certain product labeling — prior to distributing a test in the US.
On May 4, an updated policy took effect that now requires companies to submit Emergency Use Authorization requests for serology tests.
The EUA submissions are required to contain more elaborate validation data and to be submitted within 10 business days of the date the new policy took effect. Specifically, the agency guided developers to confirm test performance by assessing a minimum of 30 positive and 75 negative specimens that were tested with an FDA authorized SARS-CoV-2 assay.
Along with the listing of tests no longer allowed to be distributed for use in the US, the agency reiterated the consequences of non-compliance: "If an EUA request is not submitted by a commercial manufacturer of a serology test within a reasonable period of time, or if significant problems are identified with such a test that cannot be or have not been addressed in a timely manner, FDA intends to remove the manufacturer and test from the notification list."
FDA said it expects any de-listed test will not be distributed, "unless and until an EUA is issued for the test," and that the agency may take additional actions as appropriate.