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| == FDA Guidelines for Off-the-Shelf software ==
| | see [[FDA Guidelines for Software Development]] |
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| ITK and VTK are to be considered as off-the-shelf (OTS) products that are used
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| for supporting a higher level medical application/product. The developer of such
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| application/product will be responsible for performing the validation processes
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| described in FDA published quidelines for the development of software-related
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| medical devices.
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| ITK and VTK are intended to be used as elements in medical applications,
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| those medical applications are the ones that can be subject of an
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| FDA approval. Whoever develop such applications has the responsibility
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| of validating their application in order to demonstrate that it is
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| appropriate for the advertised purpose.
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| For example, if you develop an application for radiation treatment
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| planning based on ITK, it is your responsibility to validate that
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| application. In the process you will have to validate that the use
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| you make of ITK satisfies the requirements of your application.
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| You will probably be using a limited set of ITK functionalities in
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| such application, therefore what you have to demonstrate is that
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| those specific ITK functionalities are behaving as expected in the
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| context of your application.
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| Note that not only you need to validate the use of ITK or VTK, but also
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| the use of any other off-the-shelf (OTS) software product used in
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| the development of your application. That will included things
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| like:
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| * Your operating system
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| * Your compiler
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| * Your OpenGL library/drivers
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| * Any other library that your application is linking to.
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| * Even your pentium processor (since some units are flawed) (see for example: [http://www.fda.gov/cdrh/comp/guidance/fod456.pdf])
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| == Software Development Practices ==
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| 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
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| * Continuous Testing via Dashboard (CTest-Dart)
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| * Version control (CVS)
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| * Configuration standarization (CMake)
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| * Bug tracking (phpBugTracker)
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| ==General Guidelines==
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| For details on the FDA Guidelines for development of software
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| for medical devices you must look at the following documents:
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| "Off-The-Shelf Software Use in Medical Devices"
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| http://www.fda.gov/cdrh/ode/guidance/585.html
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| "General Principles of Software Validation;
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| Final Guidance for Industry and FDA Staff"
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| http://www.fda.gov/cdrh/comp/guidance/938.html
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| (PDF printer friendly version is available).
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| "Guidance for the Submission Of Premarket Notifications
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| for Medical Image Management Devices"
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| http://www.fda.gov/cdrh/ode/guidance/416.html
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| "Guidance for FDA Reviewers and Industry Guidance
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| for the Content of Premarket Submissions for Software
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| Contained in Medical Devices"
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| http://www.fda.gov/cdrh/ode/57.html
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