[Insight-users] FDA approval

[Luis Ibanez]

Hi John,


Here are some documents that may contribute
to the discussion on this topic.

Information about FDA requirement for Software
Validation are available from:

http://www.fda.gov/cdrh/comp/guidance/938.html

Among the multiple topic addressed in this document you
may find a set of principles for software validation.
(in section 4).

ITK uses a pretty robust software development process.
I will adventure to say that few software projects
run nightly dashboards on a dozen of different
platforms/configurations and perform continous builds
to ensure that errors introduced in the system will be
detected no later than three hours from their arrival.

The fact of being an open source project also offers
a natural mechanism for auditing the code. There are
many eyes around the world looking at every line of
code. An in-house development project could hardly
afford such extensive revision.


We may probalby say that ITK could be considered as
off-the-shelf software when used as a component of
a specific application project. In this case, the
following FDA document may be of interest:

http://www.fda.gov/cdrh/ode/guidance/585.html


The following document provides details about
the information required on submission for
FDA approval of software contained in medical devices.

http://www.fda.gov/cdrh/ode/57.html





   Luis



====================================================

John Biddiscombe wrote:

> Hello all,
> 
> I went to a job interview the other day and asked the interviewer if they
> used things like ITK at all.
> 
> The reply was essentially, that their software needed FDA approval so they
> had to go through a fairly rigorous
> specification/design/implementation/testing regime that meant they only
> generally used software written in house.
> 
> Can ITK be used in projects that require FDA approval? I assume since lots
> of medical minded people are using it, this kind of question must have
> arisen. The testing (thanks to Dart etc) must be second to none. Can anyone
> comment?
> 
> thanks
> 
> JB
> 
> 
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