Need info to try to rebut WC decision..

I just located an FDA review site that may help.
fdareview.org
Check the Medical Devices sections. It discusses that when a drug or device is FDA approved that it then can be used at the doctor's descretion even if it is not the intended original use. It is called "off label" use. An interesting example was using aspirin for heart problems and antibiotics for stomach ulcers. Don't know if this site will help but it might be another resource.

[Mariaa]

ans..
You're incorrigible..
Is the finders fee for me or him?

[Mariaa]

Alikin,
I think you hit the nail on the head..
This is the website and place to get the real deal info about what is and isn't able to be done.

I also read something about if a device is very similar to another device it may skip the premarket period and move forward so perhaps the Pro disc isn't going to have to go thru all that the Charite' did to be approved?? Or perhaps another or other discs (implants/devices) that are very similar to one another..

Good link Alikin, thanks so much!

I also read on an investment web site that the Prodisc device doesn't actually need to go through an advisory committee to be approved. However, I just spoke to my orthopedic surgeon who advised that he has learned that the approval is expected to be in the 1st quarter of 2006 regardless of whether it goes to committee of not.

[Mariaa]

Wowwwww...awesome...

Would have made a nice Christmas present!!

[JL]

I just got the "not approved" and "experimental" routine at an informal WC hearing this morning. I didn't even get upset because this all has to work out somehow. I just sat there. In my opinion they looked pretty stupid now that I got fixed. Eventually it will be obvious. Wanna know something? If their argument is true, I would think some form of humanity would have risen within them to ask how the "experiment" is going so far? Not.