FDA Proposes New Regulation Requirements for Medical Gases Today, FDA announced proposed regulations that would establish certification regulations for certain medical gases and amend the requirements for current good manufacturing practice (CGMP), postmarketing safety reporting, and labeling. FDA has engaged with stakeholders and Congress for several years to gather input and evaluate the need for regulatory changes within the medical gas industry. If finalized, this proposed rule would clarify the regulatory obligations of entities that manufacture, process, pack, label, or distribute medical gases. Examples of proposed key provisions include: - Proposed labeling requirements to clarify the statement of ingredients and quantity of contents, revise warning statements for certain designated medical gases, and establish more limited labeling requirements for bulk or transport containers.
- Proposed CGMP requirements that recognize important differences in how medical gases are manufactured, labeled, and distributed, including the reuse of containers and labeling; mixing and commingling of gases; that gases are generally manufactured in a closed, pressurized system; and that many medical gases are generally not expected to expire or degrade.
- Proposed regulations to codify the certification process for designated medical gases, including provisions regarding supplemental applications, annual reporting, and withdrawal or revocation of approval of an application.
- Proposed safety reporting requirements that recognize certain events related to designated medical gases need not be reported to the Agency.
Upon publication, FDA will accept either electronic or written comments for 90 days.
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