Shouldn't the FDA require that manufacturers provide evidence that consumer medical devices can be used reliably for their intended purpose?
What makes you think the FDA doesn't require this?
What makes you think the FDA doesn't require this?
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...