Final FDA Human Factors Guidance

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Did you know that the primary reason for device recalls is due to poor design control?  This guidance document (“Applying Human Factors and Usability Engineering to Medical Devices” published Feb. 3 2016) is critical for both device and combination product manufacturers. It can help you establish the path for ensuring that the design of the medical device or the drug delivery system has been developed with human factors in mind to minimize potential use errors and resulting harm.  Understanding how the user interface design affects interactions people have with technology and the environment where device is used can ensure the products form, fit and function addresses patient needs.  This guidance includes a template of the outline and content expected of the human factor report that should be issued for each device going to market, considerations for determining sample sizes for human factors validation testing, and guidance on analyzing results of human factors validation testing.

Learn more and download the guidance document here.