FDA to reclassify CO(2) and oxygen monitors:
This article was originally published in Clinica
Executive Summary
The FDA has issued a guidance document on filing a premarket notification application for cutaneous carbon dioxide and oxygen monitors. At the same time, it proposes to reclassify these products in light of the new document. Cutaneous carbon dioxide monitors will be reclassified from class II (need to comply with performance standards) to class II (need to comply with special controls) - the guidance document; and the cutaneous oxygen monitor for an infant patient not under gas anaesthesia is reclassified from class II performance standards into class I special controls, while the cutaneous oxygen monitor for all other uses will be downclassified from the high-risk class II category requiring premarket approval into class II special controls. Comments on the reclassification are due by April 15.
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