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# Flu Test Modification Enforcement Discretion Policy
- URL: https://www.fdaweb.com/flu-test-modification-enforcement-discretion-policy/
- Published: 2020-10-14T12:00:00.000Z
- Updated: 2026-09-14T16:32:27.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5147870

FDA has issued an immediately-in-effect guidance, *Enforcement Policy for Modifications to FDA-Cleared Molecular Influenza and RSV Tests During the Coronavirus Disease 2019 (Covid-19) Public Health Emergency*, to provide a policy to help expand access to certain FDA-cleared molecular assays intended for detection and identification of influenza (flu) viruses, including those molecular influenza assays that also detect and identify respiratory syncytial viruses (RSV), during the flu season and for the duration of the Covid-19 public health emergency. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-modifications-fda-cleared-molecular-influenza-and-rsv-tests-during-coronavirus?ref=fdaweb.com) is to remain in effect only for the duration of the Covid-19 public health emergency.

The guidance says there is a significant overlap in warning signs and symptoms between SARS-CoV-2 and other respiratory viral infections, including influenza and RSV. The diagnostic tests for the infections generally use many of the same components, it says.

“Increased availability of molecular influenza tests during the Covid-19 pandemic is important due to the similarity in symptoms between Covid-19 and seasonal influenza,” FDA says. “In addition, due to the similarity of the symptoms, and for the convenience of patients, molecular influenza tests are often offered as part of a panel of tests including RSV, which generally share an increased rate of onset during the influenza season. The importance of an accurate diagnosis of influenza can provide timely information for those patients during the Covid-19 pandemic suspected of respiratory viral infection(s). FDA believes the policy set forth in this guidance may help address public health concerns regarding the availability of molecular influenza tests during the Covid-19 pandemic and in particular during the influenza season.”