[Insight-users] FDA Approval & ITK

[Luis Ibanez]

Hi Tuhin,


Since your question is quite relevant for many ITK users,
we just added an entry for it on the ITK FAQ:

        http://www.itk.org/Wiki/ITK_FAQ

more specifically at:

   http://www.itk.org/Wiki/ITK_FAQ#Is_ITK_FDA-Approved_.3F

with a link to

http://www.itk.org/Wiki/FDA_Guidelines_for_Software_Developement



   Regards,



      Luis



---------------------
Luis Ibanez wrote:

> 
> 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
>>
> 
> 
> 
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