November 11, 2013
By Pamela Davol, Clinical & Regulatory Project Manager
A recent discussion in an online industry group posed the question, Is Usability Research Necessary for your FDA Submission?
The reply was as follows-
There should no longer be a debate or even a question as to whether or not usability studies are required for a regulatory submission of a medical device or product containing a medical device constituent (i.e. combination product with device-delivery system): a manufacturer will not get a new device or combination product with device clearance/approval without usability testing; and even some manufacturers who are making changes to previously cleared/approved devices are being asked to conduct usability testing based on changes to the design-user interface of predicate devices.
A more current question that device and drug-delivery-device manufacturers are asking is whether or not one can simply do a quick usability validation study just prior to a regulatory submission in order to “check-off the box.” At best, the answer is that even a manufacturer of a non-complex or off-the-shelf delivery-device will face challenges. Why? Because although FDA Human Factors Engineering and Usability (HFE&U) reporting veers from the 14971 and 62366 standards with regard to residual risk acceptance and justification methods, a risk-based approach is still the foundation of the HFE&U Report and is required to be included in a manufacturer’s product regulatory submission whether it be a 510(k), PMA, NDA or BLA submission. There is a burden-of-proof on the manufacturer to present objective evidence that product design and labeling choices throughout product development have been made with risk evaluation and mitigations in mind, and that such decisions have been proven effective for reducing harms and/or product inefficacy through usability testing at various stages throughout the product development. Invariably, regulatory submissions containing HFE&U Reports providing well-delineated risk assessment methods (section 4) integrated with formative testing to show evolution of the design-user interface from a human factors perspective (section 5) prior to full-product usability validation, are typically the most successful in meeting FDA guidelines.
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