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
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 Emergency. 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.
Online resources:
- Interim Guidance for Rapid Antigen Testing for SARS-CoV-2
- How to Report COVID-19 Laboratory Data
- Frequently Asked Questions about Coronavirus for Laboratories
- COVID-19 Information for Laboratories
- CDC COVID-19 website
- Clinical Laboratory COVID-19 Response Calls
- CDC Laboratory Outreach Communication System (LOCS)
- Register for CDC Health Alert Network (HAN) notifications, including updates about COVID-19. Enter your email address, search for HAN, and sign up
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)