33## FDA guidelines for off-the-shelf software
44
55ITK and VTK are to be considered as off-the-shelf (OTS) products that
6- are used for supporting a higher level medical application/product. The
7- developer of such application/product will be responsible for performing
6+ are used for supporting a higher level medical application/product. Developers
7+ of such applications or products are responsible for performing
88the validation processes described in FDA published guidelines for the
99development of software-related medical devices.
1010
1111ITK and VTK are intended to be used as elements in medical applications,
1212those medical applications are the ones that can be subject of an FDA
13- approval. Whoever develop such applications has the responsibility of
13+ approval. Developers of such applications have the responsibility of
1414validating their application in order to demonstrate that it is
1515appropriate for the advertised purpose.
1616
1717For example, if you develop an application for radiation treatment
1818planning based on ITK, it is your responsibility to validate that
19- application. In the process you will have to validate that the use you
20- make of ITK satisfies the requirements of your application. You will
19+ application. In the process you will have to validate that your use
20+ of ITK satisfies the requirements of your application. You will
2121probably be using a limited set of ITK functionalities in such
2222application, therefore what you have to demonstrate is that those
2323specific ITK functionalities are behaving as expected in the context of
2424your application.
2525
2626Note that not only you need to validate the use of ITK or VTK, but also
2727the use of any other off-the-shelf (OTS) software product used in the
28- development of your application. That will included things like :
28+ development of your application. This includes :
2929
3030- Your operating system
3131- Your compiler
@@ -35,7 +35,7 @@ development of your application. That will included things like:
3535
3636## Software development practices
3737
38- It is worth to point out that the software development process using in
38+ It is worth it to point out that the software development process using in
3939ITK and VTK are already following many of the FDA Guidelines for
4040software development. In particular
4141
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