That doesn't mean the FDA doesn't ask for data.
I have a friend who works in the industry and it's his job to run usability trials for medical devices. The FDA won't approve a device without it.
I have a friend who works in the industry and it's his job to run usability trials for medical devices. The FDA won't approve a device without it.
But for EpiPen, it seems that the process didn't work, because 60% of consumers apparently can't use the device reliably. I hope that EpiPen is an anomaly, and not typical for FDA-approved lifesaving consumer medical devices.
[1] http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidanc...