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The fact that three out of five people trained to use this lifesaving product weren't able to.
by helloworld 10y ago
The fact that three out of five people trained to use this lifesaving product weren't able to.
- refurb 10y agoThat 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.
- helloworld 10y agoYou'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...