[helloworld]

In the study below, moms of kids with severe allergies were trained to use the EpiPen. Six weeks later in a simulated test, only about two out of five were able to successfully deliver a lifesaving dose of adrenaline.

Shouldn't the FDA require that manufacturers provide evidence that consumer medical devices can be used reliably for their intended purpose?

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4654245/

Patients’ ability to treat anaphylaxis using adrenaline autoinjectors: a randomized controlled trial. Allergy. 2015 Jul; 70(7): 855–863.

[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]

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

[refurb]

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]

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...

[maxerickson]

They should allow reasonably safe products that are among the best available options.

So if people can use an Epipen more reliably than they can prepare an injection, allow it to be marketed. If someone with a history of anaphylaxis is better off with an Epipen than they are with no treatment at all, allow it to be marketed.