Navigating the Gray Area of Post- HF Validation Design Changes: The Impact of Design Changes and How to Assess Them
TimeTuesday, April 133:30pm - 3:50pm EDT
LocationMedical and Drug Delivery Devices
DescriptionWe propose to deliver a presentation that addresses considerations for when to conduct supplemental and/or re-validation testing based on a manufacturer’s anticipated product changes after validation. FDA’s final Human Factors Engineering (HFE) guidance states that “Design modifications made in response to human factors validation testing results to eliminate or reduce unacceptable use-related risks should be evaluated in a subsequent test.” However, assessing whether changes are warranted and/or if further testing is required to validate those changes can be a more nuanced assessment for manufacturers. Furthermore, there is limited documented guidance regarding the scope of these additional testing efforts.
As human factors consultants, we frequently receive questions related to determining 1) whether changes are necessary in response to an HF validation test’s results, 2) if those changes warrant additional testing, and 3) how to assess these changes when additional testing is deemed necessary. At a high-level, the answer is simple – if any changes deemed necessary are associated with critical tasks, then these changes should be assessed with further testing. However, as always, there are nuances to consider with this guideline. For example, what if an implemented change relates to a critical task but might unequivocally “design out” the remaining risk, without introducing new risk? Or, what if the product’s user interface remains the same, but the training is revised? What if the change relates to one or more critical tasks but is intended to improve usability and is unrelated to safety? Determining whether supplemental testing is necessary can often fall into a gray area.
In our presentation, we plan to explore the nuanced considerations associated with supplemental HF validation testing. We first will outline the various types of changes that manufacturers might consider in response to HF validation test results, and then whether those changes might be likely to warrant additional testing. We will also address the considerations associated with the scope of re-testing, such as reductions or modifications to user groups and/or evaluation activities. We will provide examples throughout the presentation to illustrate these considerations and situations, and our recommended approaches for determining the need to re-test and the scope of any necessary supplemental testing. We will base our recommendations on our extensive experience guiding manufacturers through these nuanced considerations, and through our various communications with FDA and understanding of their expectations.