Policy for the temporary use of portable cryogenic containers not in compliance with 21 CFR 211.94(e)(1) for oxygen and nitrogen during the COVID-19 public health emergency
- Collection:
- Health Policy and Services Research
- Series Title(s):
- Guidance for industry
- Contributor(s):
- United States. Department of Health and Human Services, issuing body. United States. Food and Drug Administration, issuing body. Center for Drug Evaluation and Research (U.S.), issuing body.
- Publication:
- [Silver Spring, MD] : Center for Drug Evaluation and Research, April 2020
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Nitrogen -- supply & distribution Oxygen -- supply & distribution COVID-19 Nitrogen -- therapeutic use Oxygen -- therapeutic use United States United States. Department of Health and Human Services. United States. Food and Drug Administration.
- Genre(s):
- Technical Report
- Abstract:
- 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. 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.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (5 pages)).
- NLM Unique ID:
- 9918227374606676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918227374606676