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by helloworld 3585 days ago
The fact that three out of five people trained to use this lifesaving product weren't able to.
1 comments
refurb 3585 days ago
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.

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helloworld 3585 days ago
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/DeviceRegulationandGuidanc...

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