FDA Issues Draft Guidance on Human Factors and Usability Engineering to Optimize Medical Device Design

• By: Staff Editor
• Date: November 11, 2011

In June 2011, the Food and Drug Administration issued draft guidance on using human factors and usability engineering to optimize medical device design. The aim of this guidance document is to help the medical device industry in conducting appropriate human factors testing and identifying device features that manufacturers should optimize throughout the total product life cycle.

This article gives a brief overview and summary of recommendations contained in this draft guidance.