On February 3, 2016 FDA published a new version of the usability guidance “Applying human factors and usability engineering to Medical Devices”. This document shows the Agency has great care of the medical device safety, trying to prevent errors and dangers during use.

Main content of this guidance is the usability requirements of the device user interface and include all possible interactions between the product and the user (i.e. display, controls, packaging, labels, instructions for use).

CDRH recommends manufacturers of some device categories listed in the guidance “List of highest priority devices for human factors review” to include usability specifications into the pre-market approval or pre-market notification applications.

For further information:
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm259760.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM484097.pdf