Sure I won't have the minutes detail of million dollar medical equipment, but maybe I don't need all that precision, or maybe that's better than having no access at all to the measurements at all
Source: I know people.
This is a government at the end of the day. It would be imprudent to not consider the effects of regulatory capture, cronyism, and so forth.
I have some experience, and i can think of about a half dozen ways cpap machines and hearing aids could cause serious harm as a result of design flaws or lack of QA that would be de rigeur if not for regulatory pressure.
Most of the ways I can think of a CPAP failing would be extremely obvious with equally obvious and relatively low-impact effects (I get a crappy night's sleep or wake up in the middle of the night).
Incorrect use of CPAP can lead to development of central apnea. (Even APAP machines can be programmed to keep the pressure too high which is long term unhealthy).
With that, I am all for liberalization of the laws. My GP did not prescribe me a CPAP machine despite obvious signs of apnea. "Lose some weight instead" (that despite me having apnea even when I had a BMI of 21).
I never felt as much of a positive difference on my life as when I started using the machine and had my first good night of sleep in decades.
I wish my govt would let me buy an insulin measurement device, but nope, those too are regulated and not available for the general public.
Do we?
I was under the impression that there has been an uptick in hearing damage in young people due to them increasing the earbud volume above background noise levels (not so much of a problem in earphones that cover the ears as they block out outside noise).
That's a medical problem that will have significant effects downstream over time and the consumer regulation really isn't working.
https://www.fda.gov/medical-devices/safety-communications/ce...
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.
These regulations are written in blood. They're difficult to comply with because if you invite poor engineering you will get poor engineering and dangerous devices.
If $DISEASE kills 10k people/year, and $DEVICE can save 90% of them but 5% suffer $DEVICE related deaths, delaying the release 10 years trying to get to 0% related deaths doesn’t sound like the best strategy.
If $DISEASE kills 10k people/year, the company manufacturing the device doesn't have to pay anything for them.
If $DEVICE kills one child, the company manufacturing the device is on the hook for several million dollars.
So your $DEVICE needs to clear (roughly) 10K*5%*$2 million per person killed or roughly $1 billion in profit to be economically feasible.
That means that those 10k people need to spend, $100K+ each for that device to make it feasible.
It's not just the FDA that makes companies want to drive that 5% down to damn near zero.
That being said I will haven't learned how to use it in a meaningful way myself. Getting a good image, and then interpreting the 2d video stream requires training!
Making ultrasound easy enough for non specialists to use will require an AI that guides the user and interprets the images. I'm not convinced skipping FDA approval would be a good idea in this case.
If you actually need to measure something, analysing the 2D images is much more precise.
EDIT: Also, it's really hard to visualise density in a 3D view.
Also,noone is stopping you from making a DIY ultrasound and selling it to enthusiasts.
https://www.fda.gov/news-events/press-announcements/fda-issu...