Zdrowie i gospodarka · 27/02/2007

Medical Devices; Anesthesiology Devices; Oxygen Pressure Regulators and Oxygen Conserving Devices

The Food and Drug Administration (FDA) is publishing a proposed rule to reclassify pressure regulators for use with medical oxygen, currently class I devices included in the generic type of device called pressure regulator, into class II, subject to special controls in the form of a guidance document. Pressure regulators for use with all other medical gases will remain in class I, subject only to general controls. FDA is also proposing to establish a separate classification regulation for oxygen conserving devices (or oxygen conservers), now included in the generic type of device called noncontinuous ventilator. Oxygen conserving devices will continue to be classified in class II, but those that incorporate a built-in oxygen pressure regulator will become subject to the special controls guidance if the rule is finalized. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a class II special controls draft guidance for industry and FDA staff entitled "Class II Special Controls Guidance Document: Oxygen Pressure Regulators and Oxygen Conserving Devices." The agency is proposing this action because it believes that special controls are necessary to p