在Part 211中范围中增加Part 213的引用,并删除正文部分中有关医用气体要求的描述。Part 211.1(a)中增加“medical gases as defined in § 213.3(b)(12)”,删除Part 211.94(e),删除Part 211.125(c) 的最后一句医用气体描述,删除Part 211.132(c)(1)中的参考“containers of compressed medical oxygen”,删除Part 211.170(b) 中描述“Reserve samples of compressed medical gases need not be retained”,删除Part 211.196 中描述“For compressed medical gas products, distribution records are not required to contain lot or control numbers”。
拟议增加的Part 213和230章节目录
21 CFR Part 213 - Current Good Manufacturing Practice for Medical Gases
医用气体现行生产质量管理规范(拟新增)
21 CFR Part 230 – Certification and Postmarketing Reporting for Designated Medical Gases
认定医用气体的认证和上市后报告(拟新增)
美国其他医用气体法律法规指南
FD&C Act Part G - Medical Gases (Sections 360ddd - 360ddd-2)