FDA Issues Final Rule Related to Medical Gases
The FDA issued a final rule revising requirements related to current good manufacturing practice (CGMP), certification, and post-marketing safety reporting and labeling that apply to certain medical gases, it said in a notice released June 17. The final rule also establishes regulations regarding the certification of designated medical gases, and it satisfies the medical gas rulemaking requirements of the Consolidated Appropriations Act of 2017, the FDA said. The rule is effective Dec. 18, 2025, although certain amendments won't go into effect until Feb. 2, 2026.
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The agency initially proposed amendments to regulations governing CGMP and post-marketing safety reporting for medical gases in May 2022 (see 2205200028). The amendments better address the unique characteristics of medical gases by allowing the tailoring of certain labeling, CGMP, certification, and post-marketing safety reporting requirements, the FDA said.
“The final rule is intended to provide clarity and consistency regarding how information is presented in the labeling of certain medical gases, as well as to ensure important safety information is included. ... The new post-marketing safety reporting regulations for designated medical gases address human and animal use and better reflect the development, manufacturing, and distribution of designated medical gases,” the FDA said.