Usability Studies and the US FDA

How do you know if your device requires usability studies? What goes into meeting the US FDA's requirements for establishing effectiveness, efficiency, and ease of use? When seeking FDA clearance for your medical device, it’s easy to be overwhelmed by various testing requirements that may or may not apply to your product. In this white paper, we’ll answer your biggest questions about usability engineering and studies, including when they might be required by the FDA and how they differ from other kinds of studies.

In this white paper, you will learn:

• What is usability engineering?
• When is usability required?
• What standards should be consulted?
• How does usability engineering differ from risk management?
• How do I conduct a usability study?
• What is the difference between usability studies and clinical studies?

We answer all of these questions and more in this 6-page white paper.

About the Author:
Robert Seiple is a Senior Quality Consultant with Emergo.