Medical devices; reclassification of the cutaneous carbon dioxide and the cutaneous oxygen monitor. Final rule.
The Food and Drug Administration (FDA) is reclassifying the cutaneous carbon dioxide (PcCO2) monitor from class II (performance standards) into class II (special controls). FDA is also reclassifying the cutaneous oxygen (PcO2) monitor for an infant patient who is not under gas anesthesia from class II (performance standards) into class II (special controls) and is reclassifying the cutaneous oxygen (PcO2) monitor for all other uses from class III (premarket approval) into class II (special controls). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document entitled "Class II [[Page 76679]] Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCO2) and Oxygen (PcO2) Monitors; Guidance for Industry and FDA" that will serve as the special control for the devices. These reclassifications are taken on the agency's own initiative based on new information. These actions are being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (the SMDA), the Food and Drug Administration Modernization Act of 1997 (FDAMA), and the Medical Device User Fee and Modernization Act.
D001785:Blood Gas Monitoring, Transcutaneous / Q000145:classification / Q000295:instrumentation*; D002245:Carbon Dioxide / Q000097:blood* / Q000737:chemistry; D018795:Device Approval; D004867:Equipment Design; D004869:Equipment Safety; D006801:Humans; D007223:Infant; D010100:Oxygen / Q000097:blood* / Q000737:chemistry; D014481:United States; D014486:United States Food and Drug Administration
D002245:Carbon Dioxide; D010100:Oxygen