Human factors of patient/user interface

In FDA's 510(k) change guidance, changes to the user interface can introduce new use errors even when the device works the same way. Such changes are assessed with human factors methods and the decision is documented.

The human factors of the patient or user interface refer to the way in which the device and the patient or user interact. This includes the way in which the device presents alarms to the user, the layout of the control panel, the mode of presentation of information to the user or patient, and the way in which the device physically interacts with the user and/or patient (e.g., the way in which a CPAP mask attaches to a patient’s face, or the way a surgical instrument is designed to fit in a surgeon’s hand).

FDA guidance: Deciding When to Submit a 510(k) for a Change to an Existing Device (October 2017), Appendix C, Significant Terminology