May 29, 2020

FDA Provides Transparency Regarding COVID-19 Antibody Test Kits

Under its Policy for Coronavirus Disease-2019 Tests During a Public Health Emergency (the "Policy"), the FDA is currently allowing manufacturers to develop and distribute validated Coronavirus-19 antibody tests as long as the manufacturer files an Emergency Use Authorization (EUA) request within 10 business days of test validation. The FDA generally issues EUAs to allow unapproved medical products or unapproved uses of approved medical products in order to help combat public health emergencies. On May 4, the FDA noted in a Policy update that "if particular commercial manufacturers that are currently marketing tests under our March 16 policy fail to submit an EUA within 10 business days," that information would be shared publicly.

Following through on that notice, on May 21, the FDA published a list of Coronavirus-19 antibody tests being removed from the current notification list of tests being offered under the Policy. The FDA removed tests from the list for which there is no current EUA in place or pending review, as well as certain other tests voluntarily removed by manufacturers themselves. The FDA's goal is to ensure public safety and welfare by continuing to provide transparent information about legitimate available antibody tests, as the current pandemic rages on.