I'm sure the FDA could be more efficient, but isn't a large part of the difficulty intrinsic to bringing a safe and effective device to the market? The flip side of people dying from not having an Epipen is people dying because their generic Epipen didn't work.
So allow devices to be labeled as "FDA approved" or "not evaluated by the FDA". Customers who value the FDA approved status can purchase those products. Customers who are comfortable determining the efficacy of a product via other means can purchase the non-evaluated products.
If no one purchases the non-evaluated product then the market will have spoken and the non-evaluated products will disappear. On the other hand if the non-evaluated products are successful then the market will have provided a better product.
