Rick - I wish the FDA didn't care "unless a doc is writing a Rx for a Segway". The way the FDA rules work, if I sell a chair that unknown to me is the best chair in the world for folks with hemorrhoids, and more than half of my sales go to people with hemorrhoids, I'm a medical device manufacturer - even if I don't know it. Worst, if I learned this and then said, "I make the best chair in the world for folks with hemorrhoids", now I'm really a medical device manufacturer. I didn't intend to be one, I didn't know I was one, but, the FDA can come in and shut me down unless I comply with their regulations. (Fortunately chairs are easy to get approval on...)
The problem is this, if Segway promotes its product as having a medical benefit then it becomes a medical device company. Then it has to get FDA approval of its personal transporter. There is no existing category for the Segway, (remember, not enough wheels), so it has to be a first time approval of a new device - this is expensive and time consuming - millions of dollars and a handful of years. The word on the street is that the iBot cost J&J about $250 million to get through FDA approval, starting in 1999 and getting approval in 2003. Imagine how expensive a Segway would be if you had to try and recover that cost, which certainly contributed to why the iBot failed as a commercial venture.
So the Catch 22 is you can go out and buy a Segway for use as your personal mobility device, but no one can sell you one as your personal mobility device - you have to figure that out on your own - or as a result of outreach from folks who are already using them. (Thank you DRAFT.)
Mud any clearer?
Quote:
Originally Posted by rickb
I don't think the FDA cares unless a doc is writing a Rx for a Segway that implies medical use to be reimbursed by Insurance companies and Medicare.
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