I am looking for a reference that cites the average time for a medical
device to reach FDA market approval.  The time should be the time from
either initial development effort or from the start of the first
clinical trials or IDE or HDE.

This should be information for a medical device and not a new
pharmaceutical drug.  I have info on PMA approval times for the FDA,
but want information that includes the time for development or
clinical trials.  If the information can be found specific to the
orthopedic device market it would be great.

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Clarification of Question by harrier-ga on 08 Jul 2003 11:56 PDT

To clarify the question, I am interested in the total time a company
would invest in moving a product from the development stage, through
IDE, clinical trials, and FDA approval.  This would be equivalent to
the information found at the following site
(http://www.allp.com/drug_dev.htm) but specific to medical devices
rather than pharmaceutical drugs.  The information should be more than
just the time for FDA approval of an IDE or PMA.

I have seen a reference to 6 years at:
http://www.sbaer.uca.edu/Research/1998/WDSI/98wds544.txt

There is no source to back it up.  I would like a cited reference or
at least more than this single source that makes reference to the time
to develop and take to market a medical device.