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[http://groups.ku.edu/cgi-bin/cgiwrap/kuksa/forum/ezboard.cgi?db=general&action=read&dbf=77 real ringtones] [http://climate.msrc.sunysb.edu/1984/messages/348.html free sonyericsson ringtones] [http://ocw201-1.usc.edu/iPIDD/ju_board/view.php?message_ID=27 buy hoodia] [http://climate.msrc.sunysb.edu/1984/messages/352.html buy tramadol] [http://www.bc.edu/apps/bookstore/cards/jun7-226422592864.html nextel ringtones] [http://groups.ku.edu/cgi-bin/cgiwrap/kuksa/forum/ezboard.cgi?db=general&action=read&dbf=54 cheap alprazolam] [http://brown.cla.sc.edu/projects/pas/bforum/index.php?method=showhtmllist&list=message&rollid=2,11 ambien online] == FDA Guidelines for Off-the-Shelf software == | | see [[FDA Guidelines for Software Development]] |
| | |
| | |
| 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 quidelines 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 pentium processor (since some units are flawed) (see for example: [http://www.fda.gov/cdrh/comp/guidance/fod456.pdf])
| |
| | |
| == 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-Dart)
| |
| * Version control (CVS)
| |
| * Configuration standarization (CMake)
| |
| * Bug tracking (phpBugTracker)
| |
| | |
| | |
| ==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"
| |
| http://www.fda.gov/cdrh/ode/guidance/585.html
| |
| | |
| | |
| "General Principles of Software Validation;
| |
| Final Guidance for Industry and FDA Staff"
| |
| http://www.fda.gov/cdrh/comp/guidance/938.html
| |
| (PDF printer friendly version is available).
| |
| | |
| | |
| "Guidance for the Submission Of Premarket Notifications
| |
| for Medical Image Management Devices"
| |
| http://www.fda.gov/cdrh/ode/guidance/416.html
| |
| | |
| | |
| "Guidance for FDA Reviewers and Industry Guidance
| |
| for the Content of Premarket Submissions for Software
| |
| Contained in Medical Devices"
| |
| http://www.fda.gov/cdrh/ode/57.html
| |
