Zdrowie i gospodarka · 12/02/2002

Medical Devices; Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCO2) and Oxygen (PcO2) Monitors; Draft Guidance for Industry and FDA; Availability

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCO 2 ) and Oxygen (PcO 2 ) Monitors; Draft Guidance for Industry and FDA." This draft guidance will serve as a special control for cutaneous carbon dioxide (PcCO 2 ) and cutaneous oxygen (PcO 2 ) monitor devices. Elsewhere in this issue of the Federal Register, FDA is publishing a proposed rule to reclassify these device types. This draft guidance is neither final nor is it in effect at this time.