FDA issues enforcement guidance for molecular influenza and RSV tests administered during COVID-19 pandemic

The Food and Drug Administration Oct. 13 issued and immediately implemented enforcement policy for modifications to FDA-cleared molecular influenza and RSV tests during the COVID-19 public health emergency to expand access to certain FDA-cleared molecular tests for detecting and identifying flu viruses and respiratory syncytial viruses.

The agency notes that these tests often require the same critical components as many SARS-CoV-2 molecular assays.