FDA Proposes to Amend Regulations on Medical Gases
FDA is proposing to amend its current good manufacturing practice and post-marketing safety reporting regulations for medical gases, it said. The proposed rule would also establish regulations “regarding certification of designated medical gases and amend the labeling regulations that apply…
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to certain medical gases,” FDA said. “This action, if finalized, will clarify the regulatory obligations of entities that manufacture, process, pack, label, or distribute certain medical gases, as well as reduce regulatory burden in this area.” Comments are due Aug. 22.