The FDA process is also extremely expensive. Not saying it justifies cost, but it is a significant upfront investment of time. Additionally, updates to the device over time have to go through approvals again.
One of the responses to the question is a respectful, reasonable post; the other responds with the typical protectionist FUD that permeates this area. The second asks about the costs of misdiagnosis by people using it inappropriately, but ignores the lost rewards of appropriate uses that are curtailed, and the costs of overpayment due to lack of competition to determine what level of training and payment is actually appropriate.
The original article might be naive about some of the technological challenges associated with an ultrasound machine, but I think that's missing the point.
When a response to "why can't anyone buy an ultrasound machine" is to disingenuously reply "because you have to have the FDA ensure that it's working correctly and people aren't running around killing each other with it," it puts huge constraints on innovation and growth in this area. I can go buy a crowbar and kill people with it, so why can't I buy an ultrasound and use it to study muscle movement, or for education, like the author of the posted article is noting?
Plenty of technically sophisticated open-source efforts exist, and they can't happen if there's arbitrary and unnecessary prohibitions on them happening. Maybe if the FDA said "hey, go to it" people would realize it's too hard, but maybe they wouldn't. We'll never know as long as there's unnecessary restrictions in the way.
> When a response to "why can't anyone buy an ultrasound machine" is to disingenuously reply "because you have to have the FDA ensure that it's working correctly and people aren't running around killing each other with it," it puts huge constraints on innovation and growth in this area. I can go buy a crowbar and kill people with it, so why can't I buy an ultrasound and use it to study muscle movement, or for education, like the author of the posted article is noting?
Nothing is stopping you making, buying, operating a toy ultrasound, so long as you make clear that it's a toy and not to be used in human health.
This isn't really how it works. The FDA will expect you to be able to produce evidence that you know it works correctly, but they're not responsible (or IMO capable) of determining whether devices work correctly. You make claims about what a device does, and you substantiate the claims with evidence. In addition, you create design and production controls that help avoid and mitigate device defects. The FDA can review your controls and defect records. The FDA will focus in particular on defects related to your device's hazards. Interestingly enough many medical device's hazards are related to the harm you might cause someone by accidentally dropping or shocking a patient or caregiver. While misdiagnosis-due-to-defect is a serious hazard, it can be mitigated to some extent by referring to the skilled physician/technician operating the device.
IMO the controls are good practices that most business would do anyways. They would give them special attention because of regulatory control. But it's true: the cost of audits and other items related exclusively to regulation aren't free, and do add some effective cost to the device.
> huge constraints on innovation and growth in this area.
I think fear of the regulation being overly burdensome does limit innovation here. Is it a net win? I'm not sure. IMO the government could mitigate this by offering DARPA-challenge style grant competitions and marketing regarding the scope of their regulatory domain.
