FDA removes some serological tests from list

May 26, 2020

The U.S. Food and Drug Administration posted a list of 28 SARS-CoV-2 serological tests that it removed from the “notification list” of tests being offered during the COVID-19 public health emergency, according to a news release.

The tests on the new removal list include those voluntarily withdrawn from the notification list by the test’s commercial manufacturer and those for which there is not a pending Emergency Use Authorization (EUA) request or issued EUA.

The FDA said it expects that the tests on the removal list will not be marketed or distributed in the United States. The tests on the list were primarily developed overseas.

On May 4, the FDA announced revised guidelines for serology tests. Under the new guidelines, the FDA gave commercial developers with tests already on the market, 10 business days to apply for an EUA. For new tests, commercial developers must apply for EUA within 10 business days from the date they notify the FDA that they have completed their validation testing on the serological assay and are marketing the product.

Under the original policy, posted March 16, the FDA allowed commercial developers to market their tests after completing internal validation studies and notifying the FDA.

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