FDA CDRH 510(k) Biofeedback Devices

“Biofeedback Devices Draft Guidance for 510(K) Content”

This document was issued in draft form in August of 1994. Section IV.B requires a hazard analysis and references the now obsolete reviewer guidance document for computer controlled medical devices, “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 used in place of this document.