Emergency Use Authorization (EUA) updates

Emergency Use Authorization (EUA) updates

FDA issues EUA for convalescent plasma FDA issued an EUA (PDF) for investigational convalescent plasma for the treatment of COVID-19 in hospitalized patients as part of the agency’s ongoing efforts to fight COVID-19. Based on scientific evidence available, the FDA concluded, as outlined in its decision memorandum (PDF), this product may be effective in treating COVID-19 and that the known and potential benefits of the product outweigh the known and potential risks of the product. Also see the FDA news release (August 23, 2020)

FDA revokes EUA for protective barrier enclosures without negative pressure due to potential risks The FDA has revoked the umbrella EUA for passive protective barrier enclosures (those without negative pressure). We carefully reviewed and considered preliminary evidence showing that there is a potential for adverse events or complications when using these devices while treating patients who are known or suspected to have COVID-19. Also see: Protective Barrier Enclosures Without Negative Pressure Used During the COVID-19 Pandemic May Increase Risk to Patients and Health Care Providers - Letter to Health Care Providers (August 21, 2020)   Diagnostic test EUAs To date, FDA has currently authorized 221 tests under EUAs, which include 179 molecular tests, 39 antibody tests, and 3 antigen tests. Also see: Coronavirus Testing Basics

Related links: FAQs on Testing for SARS-CoV-2 (frequently updated) Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices