It doesn't imply it will never malfunction. It implies it went through a scientifically rigorous process to minimize the chances it will malfunction.

And often that there's warranties in place - that is, if it does fail under normal operation, you can sue them and get millions. Which won't buy your loved one back but it's a strong deterrent for the company to not try and palm off dysfunctional shit.

that doesnt help if youre dead or severly injured...besides how many of these cases actually go to court and win?

It doesn't fix those things, but it does help deal with them, at least where the long-term financial impacts are concerned.

You're not going to squeeze a lifetime worth of lost salary out of a random Redditor who told you how to tweak your insulin pump.

It really just implies that the odds are sufficiently improved. Which may or may not be true, but which has a much better shot at it.

often times products are expedited through this ‘scientific process’ to get on the market faster. if the regulatory process is truly about safety why does this exception even exist?

Whether it's actually a good idea isn't something I know enough of the real numbers to comment on, but it seems plenty possible that an expensive step that substantially reduces risk might be appropriate in some circumstances and not in others.

> if the regulatory process is truly about safety why does this exception even exist?

Because the risk is worthwhile at times.

The exceptions typically apply to rare diseases that impact a population too small to be profitable enough to justify the $1B or more it may cost to shepherd a device or medication through the normal process.

These are populations who would be potentially unserved otherwise. (I'm of the personal opinion that this is where the government should step in instead of private industry, but I'm pretty left of center.)

https://www.fda.gov/industry/developing-products-rare-diseas...

IIRC, an exception of this sort was used to expedite an Ebola vaccine due to the recent outbreak... because, well, Ebola.