The Food and Drug Administration (FDA) updated its frequently asked questions (FAQs) on testing for SARS-CoV-2.
Some commercial manufacturers who had already validated and intended to distribute a diagnostic test, under Section IV.C of the Policy for Coronavirus Disease-2019 Test, were removed from the notification list.
Failure by a commercial manufacturer to quickly submit an emergency use authorization (EUA) request can result in the removal of the manufacturer and test from the notification list by the FDA, according to the FDA FAQs.
Additionally, if there are problems with the test that cannot or have not been addressed, the manufacturer and test will be removed from the notification list.
A commercial manufacturer can withdraw their test notification as well. Those tests are then noted with an asterisk, the FDA FAQs state.