FDA CDRH 510(k) Intrapartum Continuous Monitors

“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“Reviewer Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review,” which is now obsolete and has been replaced by the new FDA software submission guidance, “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.”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.

62304 Software Training Course – February 23-25, 2021

IEC 62304 and Emerging Standards and FDA Expectations for Medical Device and Health IT Software – Virtual

This very popular 3-day course provides a clear understanding of applying IEC 62304 standard for medical device software and much more. The course compares and contrasts 62304 with FDA expectations and discusses approaches for alignment. In addition, participants will learn of other relevant standards and technical reports pertinent to medical device software, HealthIT, medical mobile apps, and Software as a Medical Device (SaMD) products (e.g., 82304, 80002-1, 14971, 80001-2-x, 62366).

Participants will gain practical advice and pragmatic experience with all types of medical software. Participants will leave with a clear understanding of how to effectively and efficiently integrate 62304 compliance into their software development lifecycle (SDLC).

Register (click):  EventZilla Registration Site

Need info?  Email us at training@softwarecpr.com

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