From 63045e7c1da5ba3a948347e551756027bc2998c5 Mon Sep 17 00:00:00 2001 From: =?UTF-8?q?Jon=20Haitz=20Legarreta=20Gorro=C3=B1o?= Date: Fri, 10 Nov 2023 20:32:51 -0500 Subject: [PATCH] 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 | 1 + .../learn/fda_off_the_shelf_sw_guidelines.md | 59 +++++++++++++++++++ 2 files changed, 60 insertions(+) create mode 100644 Documentation/docs/learn/fda_off_the_shelf_sw_guidelines.md diff --git a/Documentation/docs/index.md b/Documentation/docs/index.md index e5131138623..5aec5aa3cd9 100644 --- a/Documentation/docs/index.md +++ b/Documentation/docs/index.md @@ -35,6 +35,7 @@ Tutorial learn/faq.md learn/courses.md +learn/fda_off_the_shelf_sw_guidelines.md ``` diff --git a/Documentation/docs/learn/fda_off_the_shelf_sw_guidelines.md b/Documentation/docs/learn/fda_off_the_shelf_sw_guidelines.md new file mode 100644 index 00000000000..ca3605cae4b --- /dev/null +++ b/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.