“Guidance Document for the Preperation of Premarket Notification [510(k)] Applications for Immersion Hydrobaths”
This document was issued July of 1995. It references the now obsolete 1991 FDA reviewer guidance “Reviewer Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review.” The current FDA software submission guidance, “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices,” should be referred to in its place. This guidance document stresses the provision of requirements and design information, development process information, verification and validation information, test results and analysis, as well as the software hazard analysis. It also stresses that provision of minimal information may not be adequate to allow the reviewer to fully assess the software and stresses that pass/fail criteria and a system level functional test plan are important to the review as well as traceability of the safety concerns throughout development.