You're right. With some Googling, I learned that the FDA does indeed have a "Human Factors Pre-Market Review Process."[1] But for EpiPen, it seems that the pro

You're right. With some Googling, I learned that the FDA does indeed have a "Human Factors Pre-Market Review Process."[1] 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/DeviceRegulationandGuidance/HumanFactors/ucm119190.htm http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidanc...