Threshold Analyses: Inspecting for User Interface Differences

Emergo by UL’s Human Factors Research & Design experts will explore challenges and best practices when conducting a threshold analysis (detailed comparison) between two products’ user interfaces, a concept first introduced by the United States Food and Drug Administration (US FDA) in 2017 and updated in 2019. During the webinar, presenters will cover key concepts when comparing differences between proposed generic and reference devices. 

The webinar will include discussions of:

  • US FDA guidance documents that address threshold analyses
  • When to perform threshold analyses during product development
  • Three types of threshold analyses
  • Categorizing and justifying design differences
  • Sample content to include in a threshold analyses report

Webinar participants will come away with practical tips and a full understanding of the types of threshold analyses, when to conduct these analyses during product development, and how to document this data.

This webinar was recorded on January 28, 2021.