Zdrowie i gospodarka · 13.12.2002
Medical Devices; Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide and Oxygen Monitors; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCO 2 ) and Oxygen (PcO 2 ) Monitors; Guidance for Industry and FDA." This guidance document describes a means by which PcCO 2 monitors and the PcO 2 monitor may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule reclassifying the PcCO 2 monitor from class II (performance standards) into class II (special controls), the PcO 2 monitor for an infant patient who is not under gas anesthesia from class II (performance standards) into class II (special controls), and the PcO 2 monitor for all other uses from class III (premarket approval) into class II (special controls).