FDA publishes Final Rule on Medical Gases

The U.S. FDA recently published a new, legally binding rule that introduces certification requirements for medical gases and amends existing GMP requirements, market product safety reporting and labelling.

Over several years, the FDA has been working with stakeholders and the US Congress to assess the need for regulatory changes in the medical gas manufacturing industry. The document "Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labelling Requirements for Certain Medical Gases" describes the regulatory obligations of companies that manufacture, process, package, label, or distribute medical gases. The Federal Food, Drug, and Cosmetic Act 575(1) specifies which gases are defined as medical gases.

The main provisions include

  • Clarification of labelling requirements regarding the indication of ingredients and their quality. Revision of warnings for certain medical gases (s. above), limitation of labelling requirements for large quantities or transport containers. 
  • Establishment of GMP requirements that take into account differences in the production, labelling and distribution of medical gases. Addressed are the reuse of containers and labelling, mixing of gases. Consideration is given to the fact that gases are produced in closed pressurised containers and that medical gases do not usually deteriorate or decompose. 
  • Regulations regarding the certification process for certain medical gases, preparation of an annual report and withdrawal or cancellation of the approval of an application by the authority. 
  • Safety reporting by the manufacturer takes into account that certain events do not have to be reported to the authority for selected medical gases.

Here you can find the new regulation "Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases".

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