Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases
other · Food and Drug Administration · Rule · Published 2024-06-18 · Effective 2025-12-18 · 89 FR 51738
Document
Document number
2024-13190
Federal Register citation
89 FR 51738
CFR reference
21 CFR 4
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2024-06-18
Effective date
2025-12-18
HHS docket
Docket No. FDA-2021-N-1333
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule revising the requirements concerning current good manufacturing practice (CGMP), postmarketing safety reporting, and labeling that apply to certain medical gases. This final rule also establishes regulations regarding certification of designated medical gases. This final rule satisfies the medical gas rulemaking requirements of the Consolidated Appropriations Act, 2017.