Coronavirus (COVID-19) Update: Daily Roundup October 13, 2020 U.S. Food and Drug Administration sent this bulletin at 10/13/2020 05:18 PM EDT If your email program has trouble displaying this email, view as a webpage. Coronavirus (COVID-19) Update: Daily Roundup October 13, 2020 The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic: Today, the FDA issued and immediately implemented a new guidance: Enforcement Policy for Modifications to FDA-Cleared Molecular Influenza and RSV Tests During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. Many molecular influenza (flu) viruses and respiratory syncytial viruses (RSV) tests require the same critical components as many SARS-CoV-2 molecular assays. The policy outlined in this guidance aims to help expand access to certain FDA-cleared molecular tests intended for detection and identification of flu viruses, including molecular influenza tests that also detect and identify RSV. Testing updates: As of today, 279 tests are authorized by FDA under EUAs; these include 217 molecular tests, 56 antibody tests, and 6 antigen tests. Additional Resources: FAQs on Testing for SARS-CoV-2 Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)
