scope:

This publication applies to manufacturers, distributors, and specification developers of medical devices used in the medical gas and gas equipment industry.

This publication does not apply to the manufacturing, reprocessing, and requalifying of cylinders or plain cylinder valves or the combining of the two because they are not classified as medical devices.

This publication is based upon:

• 21 CFR Part 830 [1];

• FDA's GUDID guidance [2]; and

• CGA PS-53, Position Statement on Pressure Regulators, Cylinder Valves, and Cylinders with Valves as Medical Devices [3].