“Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCO2) and Oxygen (PcO2) Monitors; Draft Guidance for Industry and FDA”.
A section is included on software and refers to the general and OTSS software submissions guidance. FDA specifically states that the level of concern of software in these monitors should be considered “moderate”.
This document supersedes the “Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCO2) and Oxygen (PcO2) Monitors; Draft Guidance for Industry and FDA” issued in Febuary 12, 2002