Emergency Use Authorization (EUA) Updates

Emergency Use Authorization (EUA) Updates

Diagnostic test EUAs During the COVID-19 pandemic, FDA has worked with more than 380 test developers who have said they will be submitting EUA requests to FDA for tests that detect the virus. To date, FDA has issued 50 individual EUAs for test kit manufacturers and laboratories, including 8 serology tests. In addition, 22 authorized tests have been added to the EUA letter of authorization (PDF) for high complexity molecular-based LDTs. FDA has been notified that more than 230 laboratories have begun testing under the policies set forth in our Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance.

Reminder: FDA Sets up 24/7 Hotline to Help Labs with Diagnostic Test Issues FDA’s 24/7 hotline (1-888-INFO-FDA, choose option *) is available for labs to call regarding difficulties obtaining supplies for collecting patient samples for COVID-19 testing, including swabs and media needed for transport and conservation of the samples. Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests Today! April 29, 2020: FDA will host a virtual Town Hall for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for SAR-CoV-2, 12:15 p.m. - 1:15 p.m. ET. New FAQs This week, FDA posted FAQs on the EUA for Face Masks (Non-Surgical) and FAQs on EUAs for Medical Devices During the COVID-19 Pandemic - For more FAQs, see: Coronavirus Disease 2019 (COVID-19) Frequently Asked Questions

Related links: FAQs on Diagnostic Testing for SARS-CoV-2 (frequently updated) Emergency Use Authorizations (Devices) FDA Combating COVID-19 with Medical Devices (PDF) Information for Laboratories Implementing IVD Tests Under EUA Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency (updated March 16, 2020)