Over the last several years, Human Factors Premarket Evaluation Team members from the Office of Device Evaluation (ODE) at the U.S. Food and Drug Administration (FDA) have developed several presentations on medical device human factors. Some of the key presentations include:
- What’s New in Human Factors Pre-Market Review? (Ron Kaye, M.A., March 2013)
- Human Factors Engineering of Combination Products and the FDA (Molly Follette Story, Ph.D., July 2012)
- FDA Perspectives on Human Factors in Device Development (Molly Follette Story, Ph.D., June 2012)
- FDA Human Factors Draft Guidance Document: Agency Expectations for Human Factors Data in Premarket Submissions (Molly Follette Story, Ph.D., March 2012)
- Human Factors Review Perspectives for Premarket Submissions FDA/CDRH: A Tale of Two Submissions (Ron Kaye, M.A. and QuynhNhu Nguyen, B.S., March 2012)
- The FDA Perspective on Human Factors in Medical Device Software Development (Molly Follette Story, Ph.D., February 2012)
- Identifying Use Errors and Human Factors Approaches to Controlling Risks (Molly Follette Story, Ph.D. and QuynhNhu Nguyen, B.S., September 2011)
- Meet the Human Factors Pre-Market Review Team at FDA’s Office of Device Evaluation (Ron Kaye, M.A., Molly Follette Story, Ph.D. and QuynhNhu Nguyen, B.S., September 2011)
- Human Factors/Usability for Medical Devices: An Historical Perspective (Ron Kaye, M.A., June 2011)
- Enhancing the Quality of Device Labeling (Molly Follette Story, Ph.D., April 2011)