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by refurb 3587 days ago
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?
1 comments
helloworld 3587 days ago
The fact that three out of five people trained to use this lifesaving product weren't able to.
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refurb 3587 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 3587 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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