FDA Issues New Enforcement Policy for Modifications to FDA-Cleared Molecular Influenza and RSV Tests During the COVID-19 Public Health Emergency

Today, 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 influenza (flu) viruses and respiratory syncytial viruses (RSV) tests require the same critical components as many SARS-CoV-2 molecular assays. The policy outlined in this guidance aims to help expand access to certain FDA-cleared molecular tests intended for detection and identification of flu viruses, including molecular influenza tests that also detect and identify RSV.

Read the Guidance

Increased availability of flu and RSV tests during the COVID-19 pandemic and flu season is important. This guidance:

Explains that for the duration of the public health emergency, the FDA does not intend to object to the following modifications to certain FDA-cleared molecular influenza and RSV tests without prior submission of a 510(k) premarket notification where the modification does not create undue risk in light of the public health emergency:
- Modifications to add certain transport media types, such as phosphate buffered saline (PBS) or
- Modifications to add anterior nares specimens and/or mid-turbinate specimens for tests cleared for use with nasopharyngeal swabs only.
Provides labeling information for modified tests and explains the importance of manufacturers following validation requirements.