Should robotic assistance devices like the rewalk require FDA approval?
The rewalk is a robotic device that straps on to your lower body, allowing people who have lost the use of their legs to walk around. The rewalk is currently awaiting FDA approval
The reason we have these government agencies like the FDA is for the public safety. If this "rewalk" you speak of went to market unapproved and caused a lot deaths and/or injuries there'd be hell to pay.
I don't see why it would be included if it's just essentially a pair of robot legs you strap on. To me it seems more like someone missing an arm driving a car, and the FDA saying they therefore have to approve the car.
I don't really see the comparison...I think it's more like a prosthetic arm for that person requiring FDA approval, which they are as far as I'm aware. Not to mention, there already are regulations and a safety approval process for cars, whereas I don't think there's an equivalent process that would cover this if the FDA didn't.
A car isn't a medical device though, or at least, a device marketed specifically to people with a medical condition/disability. I think there's issue of potentially compromised judgement with sensitive populations that warrants regulation (i.e., offering someone who has been paralysed the ability to walk again isn't the same as offering them something they're not particularly more likely to want/need than someone without a disability).
No, prosthetics are mostly exempt (class 1) from FDA approval (Apart from intrusive prosthetics, like prosthetic heart valves, for example. The rewalk has been listed as class 2.
In the UK, that restriction isn't there. So someone stuck in a wheelchair could have spent the last couple of years walking around in the UK, but in the US they're not allowed for home use.
In 2012 someone did the london marathon in a rewalk.
Isn't the exemption basically just a generic approval for all devices that match a specified criteria (i.e. we've approved prosthetic arms that work in a certain way, we don't need to see every new model on the market if you can justify that it matches) though?
I thought the MHRA oversaw a similar system in the UK (also in respect to EU standards), but I imagine they have different standards in terms of what gets generic approval/what the standards for it are/who has to see the evidence.
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