Emergency Use Authorization (EUA) Updates

Emergency Use Authorization (EUA) Updates

FDA makes reference panel available to test developers On May 27, 2020, the FDA further supported its effort to evaluate diagnostic tests of COVID-19 by providing a SARS-CoV-2 reference panel. This panel is an independent performance validation step for diagnostic tests of SARS-CoV-2 infection that are being used for clinical, not research, purposes. The FDA panel is available to commercial and laboratory developers who are interacting with the FDA through the pre-EUA process or whose tests have been issued an EUA. The FDA will provide the reference panel to developers at the appropriate stage in the process. There is no need for these test developers to take additional action in order to receive the reference panel.

New template On May 29, 2020, FDA took steps to further support the development of COVID-19 tests for at-home self-collection by providing on its website a template that may be used to facilitate submission of EUA requests for at-home sample collection kits. Additional respirator decontamination system authorized On May 27, 2020, FDA issued an EUA (PDF) for the Stryker Sustainability Solutions (SSS) VHP N95 Respirator Decontamination System (RDS). This product uses vapor hydrogen peroxide (VHP) to decontaminate compatible N95 respirators that are, or potentially are, contaminated with SARS-CoV-2 or other pathogenic microorganisms for multiple-user reuse by healthcare personnel to prevent exposure to pathogenic biological airborne particulates when there are insufficient supplies of face-filtering respirators (FFRs) resulting from the COVID-19 pandemic. Read more in the May 28, 2020 Daily Roundup.   Diagnostic test EUAs During the COVID-19 pandemic, the FDA has worked with more than 400 test developers who have already submitted or said they will be submitting EUA requests to the FDA for tests that detect the virus or antibodies to the virus. To date, the FDA has authorized 119 tests under EUAs, which include 103 molecular tests, 15 antibody tests, and 1 antigen test.

Related links: What is an EUA? (video) FAQs on Diagnostic Testing for SARS-CoV-2 (frequently updated) EUA Authorized Serology Test Performance FDA Combating COVID-19 with Medical Devices (PDF) Contacts for Medical Devices During the COVID-19 Pandemic