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.