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DOC: Edit phrasing and grammar of FDA software development guidelines (InsightSoftwareConsortium#5991)
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Documentation/docs/learn/fda_sw_development_guidelines.md

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## FDA guidelines for off-the-shelf software
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ITK and VTK are to be considered as off-the-shelf (OTS) products that
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are used for supporting a higher level medical application/product. The
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developer of such application/product will be responsible for performing
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are used for supporting a higher level medical application/product. Developers
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of such applications or products are responsible for performing
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the validation processes described in FDA published guidelines for the
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development of software-related medical devices.
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ITK and VTK are intended to be used as elements in medical applications,
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those medical applications are the ones that can be subject of an FDA
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approval. Whoever develop such applications has the responsibility of
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approval. Developers of such applications have the responsibility of
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validating their application in order to demonstrate that it is
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appropriate for the advertised purpose.
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For example, if you develop an application for radiation treatment
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planning based on ITK, it is your responsibility to validate that
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application. In the process you will have to validate that the use you
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make of ITK satisfies the requirements of your application. You will
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application. In the process you will have to validate that your use
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of ITK satisfies the requirements of your application. You will
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probably be using a limited set of ITK functionalities in such
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application, therefore what you have to demonstrate is that those
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specific ITK functionalities are behaving as expected in the context of
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your application.
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Note that not only you need to validate the use of ITK or VTK, but also
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the use of any other off-the-shelf (OTS) software product used in the
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development of your application. That will included things like:
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development of your application. This includes:
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- Your operating system
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- Your compiler
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## Software development practices
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It is worth to point out that the software development process using in
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It is worth it to point out that the software development process using in
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ITK and VTK are already following many of the FDA Guidelines for
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software development. In particular
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