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COVID-19 Public Health Emergency Policy on COVID-19-Related Sanitation Tunnels Guidance for Industry and Investigators February 2022

Final Level 1 Guidance
Docket Number:
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic.

Because of significant concerns for human safety, FDA is issuing this guidance to discourage sponsors from developing or seeking approval or authorization for the use of sanitation tunnels, also known as disinfection tunnels or sanitizing tunnels. Sanitation tunnels are tunnels, walkways, chambers, and similar systems that use sensor-based nozzles to spray humans (and their clothing) with a mist of disinfectant or aerosolized antiseptic as they walk or ride through these tunnels.. First installed in China, these tunnels have been developed in countries outside of the United States with the aim of treating or reducing the spread of COVID-19. Sanitation tunnels are generally located outside crowded places such as food markets, shopping malls, hospitals, police stations, airports and train stations, offices, and industrial complexes.

Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2020-D-1136.

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