Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases - FINAL RULE

The Food and Drug Administration (FDA, the Agency, or we) is establishing new regulations that amend current good manufacturing practice (CGMP) requirements, postmarketing safety reporting, and product labeling, that apply to certain medical gases. Conforming changes are also being made in associated regulations that apply to medical gases. The regulations are intended to promote greater efficiency in the regulation of medical gases while helping to ensure that they adhere to all applicable safety and quality standards.

The latest form for Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases - FINAL RULE expires 2028-02-29 and can be found here.

Labeling of medical gas containers (Table 2 from FINAL RULE)

Federal Enterprise Architecture: Health - Consumer Health and Safety