
New FDA Labeling Requirements for Medical Gas Cylinders
The U.S. Food and Drug Administration (FDA) has issued a Final Rule amending several sections of Title 21 of the U.S. Code of Federal Regulations (CFR), setting the stage for notable changes across the medical gas industry. Published on June 18, 2024, this rule revises requirements around current good manufacturing practice (CGMP), postmarketing safety reporting (pharmacovigilance), and—most notably for compressed gas firms—labeling for designated medical gases.