On: EpiPen Price Rise Sparks Concern for Allergy Sufferers

[refurb]

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?

[helloworld → refurb]

The fact that three out of five people trained to use this lifesaving product weren't able to.

[refurb → helloworld]

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.

[helloworld → refurb]

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...