[slicer-users] slicer-users Digest, Vol 60, Issue 21

Ron Kikinis kikinis at bwh.harvard.edu
Fri Mar 26 07:12:00 EDT 2010


Hi,

I am not a lawyer, but here is my understanding:
FDA approval is a rigorous and focused endeavor. You would not get 
Slicer FDA approved, but rather get Slicer FDA approved for a specific 
task or procedure. Using Slicer for something else would be "off-label" use.

FDA needs a package to be unchanged, well characterized and documented. 
I would love to claim the latter two features for Slicer (you have seen 
my email from yesterday) but first requirement of unchanged makes it 
difficult to use Slicer as a research platform for technology research.

Finally, FDA "only" covers the the US, Slicer is used worldwide.

Having said all of this, the Slicer license would allow somebody else to 
take a version of Slicer and get it FDA approved for a particular task 
or procedure. This could be done without the need for additional license 
negotiations.

Ron

On 3/25/10 11:28 PM, rk tumuluri wrote:
> Hi all,
>
>   Apologies for this "naive question". I am "newbie" to this forum.
>
>   Given that Slicer is largely a NIH funded initiative, what is the holdup in
> getting the requisite FDA approval.
>
>   A commercial vendor such as ablesw claims FDA approval for
> Their comparable offering i.e "3D Doctor".
> http://ablesw.com/3d-doctor/k003746.pdf
>
> Regards
> /rk
> ----------------------------------------------------------------------
>
> Mohan,
> Remember that Slicer is not FDA approved and that you need to make sure
> that you have appropriate approvals (IRB and such) if you plan to use
> Slicer to analyze patient data.
> Ron
>
>
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-- 
Ron Kikinis, M.D.,
Robert Greenes Distinguished Director of Biomedical Informatics
Professor of Radiology, Harvard Medical School
Director, Surgical Planning Laboratory
http://www.spl.harvard.edu/~kikinis



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