10/17/2020: Lab Advisory: Enforcement Policy for Modifications to FDA-Cleared Molecular Influenza and RSV Tests During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

CDC's Laboratory Outreach Communication System (LOCS)

Audience: Clinical Laboratory Professionals

Level: Laboratory Advisory

On Monday, October 13, the U.S. Food and Drug Administration (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 Emergencyexternal icon. Many molecular tests for influenza (flu) viruses and respiratory syncytial viruses (RSV) require the same critical components as many SARS-CoV-2 molecular assays. The policy outlined in the new guidance aims to help expand access to certain FDA-cleared molecular tests intended to detect and identify flu viruses, including molecular influenza tests that also detect and identify RSV.

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If you have any questions, please contact us at LOCS@cdc.gov.

Thank you,

The Laboratory Outreach Communication System

Laboratory Outreach Communication System | Division of Laboratory Systems (DLS)

Center for Surveillance, Epidemiology, and Laboratory Services (CSELS)

Centers for Disease Control and Prevention (CDC)

LOCS@cdc.gov

www.cdc.gov/csels/dls/locs

Page last reviewed: October 19, 2020