IDA Device Usability Study: Meeting FDA Standards

Advancing FDA Compliance Through Human Factors Research

See how our comprehensive usability evaluation of the IDA Device—conducted in compliance with FDA human factors guidance—revealed important insights about consumer interaction with this light-based wrinkle treatment system, and how addressing these findings can create a more effective product experience while meeting strict regulatory requirements for over-the-counter medical devices.

In this case study, URI discovered:

  • Consumers demonstrated high accuracy in self-selection decisions, supporting the regulatory case for over-the-counter classification.
  • Several participants encountered difficulties with device signaling that impacted their ability to follow the proper treatment sequence.
  • The study identified opportunities to improve how users interact with the device’s consumable elements.
  • Participants showed excellent comprehension of key safety information, strengthening the regulatory submission for FDA review.
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