DOC: Transfer the wiki FDA SW guidelines page to Markdown documentation

Transfer the wiki FDA SW guidelines page to Markdown documentation:
https://itk.org/Wiki/FDA_Guidelines_for_Software_Development.

Update the links as necessary.

Documentation/docs/index.md

@@ -35,6 +35,7 @@ Tutorial <https://github.com/InsightSoftwareConsortium/ScientificImageAnalysisVi
 Software Guide <https://itk.org/ItkSoftwareGuide.pdf>
 learn/faq.md
 learn/courses.md
+learn/fda_off_the_shelf_sw_guidelines.md
 ```
 
 

Documentation/docs/learn/fda_off_the_shelf_sw_guidelines.md

@@ -0,0 +1,59 @@
+# 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 developement. In particular
+
+- Continuous Testing via Dashboard ([CTest](https://cmake.org/cmake/help/latest/manual/ctest.1.html))
+- Version control ([git](https://git-scm.com/))
+- Configuration standarization ([CMake](https://cmake.org/))
+- Bug tracking ([GitHub](https://github.com/features/issues)/[GitLab issues](https://docs.gitlab.com/ee/user/project/issues/))
+
+## 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](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/shelf-software-use-medical-devices)
+- [General Principles of Software Validation](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-principles-software-validation)
+- [Guidance for the Submission Of Premarket Notifications for Emission Computed Tomography Devices and Accessories (SPECT and PET) and Nuclear Tomography Systems](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-submission-premarket-notifications-emission-computed-tomography-devices-and-accessories)
+- [https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submission-premarket-notifications-magnetic-resonance-diagnostic-devices](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submission-premarket-notifications-magnetic-resonance-diagnostic-devices)
+- [Guidance for the Submission of Premarket Notifications for Photon-Emitting Brachytherapy Sources - Guidance for Industry](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-submission-premarket-notifications-photon-emitting-brachytherapy-sources-guidance-industry)
+- [Guidance for the Submission of Premarket Notifications For Radionuclide Dose Calibrators - Guidance for Industry](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-submission-premarket-notifications-radionuclide-dose-calibrators-guidance-industry)
+- [Content of Premarket Submissions for Device Software Functions](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/content-premarket-submissions-device-software-functions)
+
+These and other relevant documents can be found at the [FDA Guidance Doument search](https://www.fda.gov/regulatory-information/search-fda-guidance-documents)
+and the [Medical Devices and Radiation-Emitting Products Guidance Documents](https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products) sites.