Because of the rising instances of UI-induced adverse events, the US Food and Drug Administration (US FDA) has begun to include HF/UE reviews as a routine part of their pre-market approval process at the Center for Devices and Radiological Health's (CDRH) Office of Device Evaluation.
Likewise, the international regulatory community has incorporated IEC 62366-1:2015 Medical devices Part 1 - Application of usability engineering to medical devices as a part of the approval process outside the US. Both the FDA HF/UE guidance and IEC 62366 outline a process including activities throughout device development, culminating in validation testing with the final UI design in simulated use environments.
This paper summarizes the major regulatory requirements for HF/UE under the US FDA and the international standard IEC 62366 that manufacturers must comply with.
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