My Nurse Case Manager asked me if I could find out what the process is for a surgeon once a device has become FDA approved in terms of going from using it at one level to two or three, or just "at his or her perogative" when it comes to ADR implant devices.
At this time WC is trying to say that the Charite has only been approved for 1 level via the FDA. My understanding is that the device is now FDA approved and there may be recommendations for usage by the manufacturer however, the surgeon would decide how to further use this device and there would be some general standards of care in the community that might guide this also.
Can anyone help me with some kind of formal documenation or guideline that a surgeon might use for say the Charite (FDA approved) implant in terms of multilevels?
thanks.. I hope I haven't garbled this question up too badly that no one can understand what I need...
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