FDA CDRH 510(k) Galvanic Skin Response

“Galvanic Skin Response Measurement Devices Draft Guidance For 510(K) Content”

This document was issued in draft form in August of 1994. Section II.B Data and Displays requires that “All displays and other output data provided by the device must be completely described in the submission” and states that “Copies of all displays produced by the device must be included, along with the numeric range, units of measurement and increments of the displays.

Section IV.B which specifically mentions software references to the now obsolete 1999 reviewer guidance document for computer controlled medical devices, “Reviewer Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review,” so the current FDA software submission guidance, “Guidance for teh Content of Premarket Submissions for Software COntained i Medical Devices,” should be used in its place. This paragraph also emphasizes that a hazard analysis must be included as well as a description of the level of concern of the device.

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