FDA Guidelines for Software Developement

FDA Guidelines for Off-the-Shelf software

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: [1])

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