FDA Publishes Revised Draft Guideline on Medical Gases

In November 2025, the FDA released the draft guideline “Medical Gases – Current Good Manufacturing Practice”, updating the 2017 version, effective 18 December 2025. The revision is more technical, clearly structured, and tailored to medical gases, aiming to reduce regulatory burden while ensuring quality, identity, and purity.

Scope:

• Applies only to medical gases classified as medicinal products (e.g., oxygen USP, nitrogen NF, carbon dioxide USP, medical air, helium).
• Excludes industrial, technical, process, and calibration gases.

Key Updates:

• Expanded guidance on quality unit responsibilities, supplier qualification, documentation, and batch release.
• Technical chapters cover filling systems, valves, cryogenic containers, leak testing, cylinder emptying, and alternative test strategies.
• Laboratory testing and CoA requirements clarified, including identity, purity, composition, and validation of alternative methods.
• Small-scale producers and cylinder transfer operations explicitly included.

The guideline provides clear regulatory expectations and practical recommendations for manufacturing, equipment, documentation, and transport.

17-12-2025