Understanding Regulatory Requirements for Human Factors Usability Testing

FDA takes these human factors requirements seriously, requiring the manufacturer to perform a systematic assessment, incorporating usability testing to determine how the device will be used, the environment in which it will be used and existing use-related hazards. Manufacturers should provide FDA with a report that summarizes the human factors processes, evaluations and results of validation testing as part of their premarket applications or submission.

This panel presentation will review FDA’s draft or final guidance and other standards for human factors engineering (HFE) usability testing. The panel will be moderated by Penny Northcutt, REGSolutions LLC, a company that provides regulatory solutions and quality systems for the life science industry.