Comment Re:Medical Device Certification? (Score 2) 91
a good deal of the cost of these things is the FDA certification
If there's no surgery, it's just a object - a tool, an item of functional clothing, more-or-less. I'd be surprised and annoyed to find out that any kind of certification was legally required for something like this.
Or that is at least the popular excuse of companies that make prosthetics.
There's also the fact that they actually are traditionally expensive to make and fit.