November 10, 2011

This Guidance paper shows the current FDA point of view regarding clinical investigations, the so called “investigational device exemptions” (IDE). Subsequent to the special requirements regarding the biocompatibility and ethical considerations for such investigations the document describes the investigational plan for such studies.

A certain bullet point which has to be mentioned within such a protocol is the risk management of the product which shall be tested during the IDE. During the description of the risk management the document states that the investigational plan needs a “…- a plan to capture human factors information during the course of the study to modify the procedures or device as necessary based on the information obtained”

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