[Insight-users] Re: Bug 1056: FDA Approval & ITK

[Luis Ibanez]

Hi Tuhin,

Given the fact that ITK is a software toolkit, it cannot be the
subject of FDA approval as a medical device. We have discussed
this topic in several occasions and received advice from FDA
representatives, that can be summarized as follow:


   ITK is to be considered as an off-the-shelf (OTS) product that
   is used for supporting a higher level medical application/product.
   The developer of such application/product will be responsible for
   performing the validation processes described in FDA published
   guidelines for the development of software-related medical devices.



ITK is intended to be used as an element in medical applications,
those medical applications are the ones that can be subject of an
FDA approval. Whoever develop such applications has the responsibility
of validating their application in order to demonstrate that it is
appropriate for the advertised purpose.

For example, if you develop an application for radiation treatment
planning based on ITK, it is your responsibility to validate that
application. In the process you will have to validate that the use
you make of ITK satisfies the requirements of your application.
You will probably be using a limited set of ITK functionalities in
such application, therefore what you have to demonstrate is that
those specific ITK functionalities are behaving as expected in the
context of your application.



Note that not only you need to validate the use of ITK, but also
the use of any other off-the-shelf (OTS) software product used in
the development of your application. That will included things
like:

         1) Your operating system
         2) Your compiler
         3) Your OpenGL library/drivers
         4) Any other library that your application is linking to.
         5) even your pentium processor (since some units are flawed)
           (see for example:
            http://www.fda.gov/cdrh/comp/guidance/fod456.pdf)


For details on the FDA Guidelines for development of software
for medical devices you must look at the following documents:



     "Off-The-Shelf Software Use in Medical Devices"
      http://www.fda.gov/cdrh/ode/guidance/585.html


     "General Principles of Software Validation;
      Final Guidance for Industry and FDA Staff"
      http://www.fda.gov/cdrh/comp/guidance/938.html
      (PDF printer friendly version is available).


     "Guidance for the Submission Of Premarket Notifications
      for Medical Image Management Devices"
      http://www.fda.gov/cdrh/ode/guidance/416.html


     "Guidance for FDA Reviewers and Industry Guidance
      for the Content of Premarket Submissions for Software
      Contained in Medical Devices"
      http://www.fda.gov/cdrh/ode/57.html




Please let us know if you have further questions,



    Thanks


      Luis



----------------------
Tuhin Sinha wrote:
> 
> I would like to ask for some verification of your last point Luis
> regarding treatment planning using ITK.  Has the Insight Toolkit been
> FDA approved?  That is, are you allowed to make clinical decisions using
> software based on the Insight Toolkit?
> 
> Best regards,
> 
> Tuhin Sinha
>