Updated April 20, 2020

The Food and Drug Administration (FDA or the Agency) 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.

As demand for oxygen and nitrogen intended for medical use increases due to the COVID-19 pandemic, FDA has become aware of concerns regarding a low supply of portable cryogenic medical gas containers and has received inquiries regarding the use of gas containers that do not meet certain regulatory requirements for portable cryogenic medical gas containers (e.g., industrial gas containers).

FDA is issuing this guidance to communicate its policy for the temporary use of certain gas containers for oxygen and nitrogen intended for medical use for the duration of the public health emergency declared by the Secretary of Health and Human Services (HHS) on January 31, 2020.