FDA CDRH 510(k) Guidance for Tens 510(k) Content

“Guidance for Tens 510(k) Content”

This document was issued in August of 1994. It defines the 510(k) premarket submission requirements for transcutanieous electrical nerve stimulators. Section D in part two of the document requires information of software in the device. It requires documentation of the software development process inculding the system requirements specification, identification of failure modes and associated hazards, procedures for software verification and validation, and the results of these activities. It also references the now obsolete 1991 reviewer guidance for computer controlled medical devices, “Reviewer Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review,” and 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.

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