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FDA PUBLISHES GUIDANCE RECLASSIFYING OXYGEN DEVICES

February 27, 2007

The FDA announced it is publishing a guidance on a proposed rule to reclassify pressure regulators for use with medical oxygen from Class I to Class II. Devices in Class II are subject to special controls.

Pressure regulators for use with all other medical gases will remain in Class I, subject only to general controls, the FDA said in its Feb. 27 Federal Register announcement. The agency is also proposing to establish a separate classification regulation for oxygen-conserving devices.

The guidance, titled "Class II Special Controls Guidance Document: Oxygen Pressure Regulators and Oxygen Conserving Devices," can be viewed at www.fda.gov/OHRMS/DOCKETS/98fr/07d-0020-gdl0001.pdf ( http://www.fda.gov/OHRMS/DOCKETS/98fr/07d-0020-gdl0001.pdf ).