Zdrowie i gospodarka · 12/02/2002

FDA Proposes Reclassification of Cutaneous CO2 and O2 Monitors

The FDA is proposing to reclassify the cutaneous carbon dioxide (PcCO2) and oxygen (PcO2) monitors from class III to class II special controls, citing new information under the Federal Food, Drug, and Cosmetic Act, as amended by the Medical Device Amendments of 1976 and the Safe Medical Devices Act of 1990.