“Intrapartum Continuous Monitors for Fetal Oxygen Saturation and Fetal pH”

This guidance document is a draft and was issued on June 14, 1997. It references software in section F. It requires information on the software development process, a safety hazard analysis including a trace matrix, and requests that software specifications, test plans, and documentation of the software development process are provided. It establishes that these devices are generally a moderate level of concern. It references the 1991 reviewer guidance for computer controlled medical devices, “Reviewer Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review,” which is now obsolete and has been replaced by the new FDA software submission guidance, “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.” In addition to the software sections, there are other sections not specifically stating software, but certainly relevant to software where it talks about algorithm characteristics, validation and human factors analysis.