[Insight-users] FDA approval

[Miller, James V (Research)]

What I have heard from the FDA is that you consider
open source software like "off the shelf" software 
and use the same mechanisms that you currently employ
to approve products that contain off the shelf software.

For instance, everyone uses OpenGL but people do not have
to validate it like they do their internal software.



> -----Original Message-----
> From: Luis Ibanez [mailto:luis.ibanez@kitware.com]
> Sent: Tuesday, November 19, 2002 11:17 AM
> To: John Biddiscombe
> Cc: insight-users@public.kitware.com
> Subject: Re: [Insight-users] FDA approval
> 
> 
> 
> 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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> > 
> > 
> 
> 
> 
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