Usability testing required for FDA IDE (investigational device exemption)?

#1
What is the general thinking about the requirement of usability testing prior to the submission of an FDA IDE? Is FDA requiring it? It seems to me that we should be able to justify using pre-clinical data that the clinical trial will be used to support usability, as long as usability is evaluated during the trial. Right?
 
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yodon

Staff member
Super Moderator
#2
I don't think I've seen any specific requirements imposed. You may need to provide assurance that potential use / usability errors won't lead to harm. Consider doing a task analysis or PFMEA and consider missteps / errors and results. Maybe training is warranted or oversight?
 

Tidge

Quite Involved in Discussions
#3
I'm sidestepping the direct question about any requirements for usability testing prior to IDE.

It seems to me that we should be able to justify using pre-clinical data that the clinical trial will be used to support usability, as long as usability is evaluated during the trial. Right?
As far as I know, this is still applicable : Applying Human Factors and Usability Engineering to Medical Devices

Relying on the IDE is probably not the same as considering 'simulated use', but the underlying concerns are roughly the same. Without knowing any details about the device, the IDE or specific usability concerns I will write this: I have a general expectation that the IDE will be able to inform elements of the usability assessment of the final product. A priori I don't expect the IDE work to completely replace the efforts during validation.
 

indubioush

Quite Involved in Discussions
#4
Usability testing should be performed early in device development. Formative evaluations can result in design changes to reduce use error. Much easier to change the design prior to the validation stage. Regulating bodies have been a bit lenient when it comes to usability, but that may change.
 
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