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FDA Releases Final Guidance on Human Factors and Usability Engineering

Testing, design and people requirements for performing human factors studies are often the most difficult for device companies, due to lack of resources and guidance understanding. However, FDA and international governing bodies expect continued scrutiny of the topic. This is evidenced by the second guidance document that FDA released during its announcement.

The second draft guidance is titled “Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development.” When final, it will represent FDA’s thinking on when and how manufacturers should perform human factors studies for combination products for investigational or marketing applications.

This document provides examples of such products and recommends ways to approach human factors studies for them, focusing on challenges, including:

  • The timing and sequencing of human factors studies as they relate to the overall development and study of a combination product
  • How human factors studies compare to other clinical studies
  • When changes to a combination product call for new human factors studies to be conducted
  • When to use simulated-use versus actual-use human factors studies
  • What information to provide to FDA, and when, to ensure timely feedback for human factors studies

The comment period for this draft guidance ends on May 3, 2016. In addition to seeking input on the guidance, FDA is requesting that stakeholders submit examples of combination products in their comments and state whether they believe human factors studies are necessary, as well as those challenges and development risks that may arise if these studies are conducted before, during or after clinical studies for combination products.

In the final guidance for human factors, FDA clarified that simulated use studies are the norm and it would be rare to require actual use studies in a clinical study, according to Israelski.

“That may be required in rare circumstances where you can’t simulate all the conditions, especially the ones that concern safety,” he says.

Changes from the 2011 draft guidance to the recently-released final guidance are minor, and have a small impact, Israelski says.

This includes slight changes to the report format that FDA wants (listed in Annex A) and small changes to definitions. Specifically, the report format is now eight sections instead of seven, and the conclusion section is in the front rather than the last section.


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