FDA guidelines for software development¶
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 guidelines 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 processor
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 development. In particular
Continuous Testing via Dashboard (CTest)
Version control (git)
Configuration standardization (CMake)
Bug tracking (GitHub/GitLab issues)
General guidelines¶
For details on the FDA Guidelines for development of software for medical devices you must look at the following documents:
These and other relevant documents can be found at the FDA Guidance Document search and the Medical Devices and Radiation-Emitting Products Guidance Documents sites.