Skip to main content
  • Feature Story

US FDA Medical & Combination Product Regulatory Submissions: Human Factors - FDA's New and Renewed Expectations About this Webinar Now Available to View Online

March 22, 2016

In this pre-recorded webinar, UL HFE experts discussed the FDA’s new and renewed expectations regarding the application of Human Factors Engineering (HFE) to medical devices that call upon users to perform critical tasks.  The discussion centered around our experts’ experience helping customers generate appropriate human factors data to support pre-market submissions. The recording includes responses to several questions posed by the attendees in this 60 minute recording.

US market access for medical devices is key to many businesses. In recent years, the US FDA has expected manufacturers to submit the results of Human Factors and Usability studies for pre-market submissions.

In early 2016, FDA issued one final and two draft Guidance documents in the area of HFE including:

  • Final Guidance - Applying Human Factors and Usability Engineering to Medical Devices
  • Draft Guidance - Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development
  • Draft Guidance - List of Highest Priority Devices for Human Factors Review

UL's HFE experts have decades of experience providing advanced HFE solutions for device manufacturers around the world.  Our team has tested hundreds of devices, many of which are included in FDA’s list of high priority devices warranting rigorous HFE. In addition to joining the webinar, feel free to reach out to UL's HFE team to help interpret the new guidance and its impact on your go to market plans.

Your Presenters:

Allison Strochlic, Research Director, UL Human Factors Engineering Practice

Allison Strochlic is the research director of UL's human factors engineering practice. She is a certified human factors professional, and has 10 plus years of experience applying HFE to medical technology and pharmaceutical product development.

Allison co-authored the first and second editions of Usability Testing of Medical Devices, and is a member of the AAMI home healthcare committee.

Michael Wiklund, General Manager, UL Human Factors Engineering Practice

Michael Wiklund serves as general manager of UL's human factors engineering practice, which includes staff working in the USA, Europe, and Asia.

A certified human factors professional, he has a total of over 30 years of experience in the field, much of it focused on medical technology development.

Michael has authored many books on human factors engineering, the latest being the second edition of Usability Testing of Medical Devices and Medical Device Use Error – Root Cause Analysis. He has also contributed extensively to the current AAMI and IEC standards and guidelines on human factors engineering. As Professor of the Practice at Tufts University, he teaches courses on human factors in medical technology and software user interface design.

Mr. Wiklund and Ms. Strochlic are co-authors of Usability Testing of Medical Devices, Second Edition, Copyright 2016, and available now on Amazon and through CRC Press.

Please Note: This webinar was recorded  Wednesday, March 16th, 2016