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

Oct 14, 2020 - 02:56 PM
FDA-guidance

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.

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