ARTICLE SUMMARY:
Some industry observers are raising concerns that a recent draft guidance from FDA would unnecessarily ramp up the number of devices subject to comprehensive human factors/usability evaluations.
FDA appears to be nudging manufacturers toward a more systematic consideration of when formal usability, or human factors, testing of devices might be needed to support a premarket submission. But some industry observers worry the agency is expanding the scope too wide, adding unnecessary burdens to both companies and FDA review staff.
That fear was triggered by a draft guidance published by FDA’s device center in December addressing the “Content of Human Factors Information in Medical Device Marketing Submissions.” The draft builds on CDRH’s growing emphasis over the past 10-15 years on medical device usability engineering in the face of device safety issues linked to preventable user errors. CDRH has bulked up its human factors staff and expertise and fleshed out its expectations for manufacturers. It published a guidance document in 2016 that lays out how companies can go about formally embedding human factors engineering and evaluating usability in devices, detailing an array of techniques to identify the “critical tasks” that are vulnerable to harmful user errors and methods for simulated- and actual-use testing.
