Enforcement Policy for Modifications to FDA-Cleared Molecular Influenza and RSV Tests During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff | NLM

Disaster Information Management Research Center | NLM

Enforcement Policy for Modifications to FDA-Cleared Molecular Influenza and RSV Tests During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff

10/13/2020 12:00 AM EDT

Source: U.S. Food and Drug Administration (FDA). Published: 10/13/2020. This nine-page guidance was issued 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 influenza season and for the duration of the COVID-19 public health emergency. (PDF)