You’d be surprised at how much is just about filling the proper paperwork, paying some fees and knowing the right people. The amount of independent testing is negligible.
You may be referring to the 510k (pre-existing predicate device) pathway, which has been abused by companies to leapfrog and skip _some_ of the more stringent test requirements, but they still need to prove similarities, and that requires real data. However, in the vast majority of cases, these devices are things like masks, IV tubing sets, etc, not complex life saving equipment, which gets an enormous amount of scrutiny. If anything, it's the medical device companies that are at fault for lobbying Congress to allow abuse of 510k pathways, and Congress for allowing these things to happen.
Paperwork, they require paperwork.
It’s the same issues that plague FCC and CE, the amount of tricks and handwaving you can get approval for makes a lot of this (self performed/self directed) testing completely useless.
There’s a whole market of “expert consultants” whose job is gaming the tests and finding loopholes, and as long as tests are conducted in this manner, they will exist.
Like I said, the world of predicate devices is a different ball game, but you're not going to get by with hand waving on a device that can kill people.
That’s not a good measure for the performance of the regulation. In fact I’d like to see the numbers on the exact reasons for those shut downs, because I’m willing to bet they’re related to bad classification and other technicalities.
If the FDA were to be a test, you’d want it to have good discrimination at a low cost.
Anyone who has been involved in the process knows the cost is enormous, and scandals like Theranos (and good but extremely late good cases) show that discrimination is not that good to begin with.
