Summative Usability Testing FDA requirements compared to 62366

Trying our best to boil a single concept into the confines of a YT short, so just understand that there are a lot of potential options and considerations beyond the single instance we are looking at in this video.

Hello everyone this is Matthew with Medical Device Academy and in this week’s usability tip we are going to look at how the FDA and 62366 take slightly different paths to get to similar summative testing results.

In the 2016 guidance the FDA defines a critical task in part as “A user task which, if performed incorrectly or not performed at all, would or could cause serious harm to the patient or user,” and also states that validation testing should include all critical tasks.

62366 takes a different approach since ‘Critical Task’ is an FDA specific concept. The standard looks at the hazard related use scenario which is a “scenario that could lead to a hazardous situation or harm”. That hazardous situation broadens the testing scope slightly from just critical tasks alone.

However when selecting the hazard related use scenarios for testing the middle option most closely aligns with the FDA guidance, since it takes the use scenarios and selects them based on harm instead of selecting the specific tasks based again on harm since that is what differentiates a critical task from just a plain task.

#fda #humanfactorsengineering #medicaldeviceregulation #medicaldeviceacademy #usabilityengineering #62366