FDA Guidelines for Software Developement: Difference between revisions

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== FDA Guidelines for Off-the-Shelf software ==
see [[FDA Guidelines for Software Development]]
 
 
ITK and VTK are to be considered as off-the-shelf (OTS) products that are 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 quidelines for the development of software-related
medical devices.
 
ITK and VTK are intended to be used as elements 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 or VTK, 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:
 
* Your operating system
 
* Your compiler
 
* Your OpenGL library/drivers
 
* Any other library that your application is linking to.
 
* Even your pentium processor (since some units are flawed) (see for example: [http://www.fda.gov/cdrh/comp/guidance/fod456.pdf])
 
== Software Development Practices ==
 
 
It is worth to point out that the Software Development Process using in ITK and VTK are already following many of the FDA Guidelines for software developement. In particular
 
* Continuous Testing via Dashboard (CTest-Dart)
* Version control (CVS)
* Configuration standarization (CMake)
* Bug tracking (phpBugTracker)
 
 
==General Guidelines==
 
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

Latest revision as of 16:17, 31 March 2009