FDA issues new guidance for molecular flu and RSV test use during COVID-19 pandemic
The U.S. Food and Drug Administration (FDA) announced it has 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.
Currently, 279 tests are authorized by the FDA under EUAs; these include 217 molecular tests, 56 antibody tests, and 6 antigen tests.
