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  • 1.  Validation for embedded software

    Posted 10-Dec-2012 11:09
    I am unclear on FDA/CDRH expectations for software validation (and whether any is needed) in the case where there may be very simple embedded software on a chip.

    The device is an OTC IVD which is basically a simple ammeter which measures transient electrical currents and is calibrated to read out intuitive numbers on a digital display. The device also displays error codes under certain limited conditions (measurement out-of-range, other error etc.) There is no other software associated with the device.

    I keep reading that "software is not hardware." Based on that I would think that performance testing should be sufficient. On the other hand it can be argued that testing is not synonymous with validation.

    Can anyone share their experience?
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    Jean Bigoney PHD
    Managing Member
    Nu Device Consulting LLC
    Newport NH
    United States
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  • 2.  RE:Validation for embedded software

    Posted 11-Dec-2012 09:01
    Jean-
    In my experience, any software that is part of a medical device must be validated.  I have worked with devices in which the software is put onto a chip, thereby making it firmware.  It is still software in the FDA's eyes and must be validated the same as any other software in a medical device.  In addition to that, we also performed a verification/QC step during manufacturing to ensure that the firmware had been installed correctly and was not corrupt.
    Debbie

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    Debbie Koeneman
    Mesa AZ
    United States
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    Original Message


  • 3.  RE:Validation for embedded software

    Posted 11-Dec-2012 09:14
    The extent of the testing needed to establish the reliability of any new software is a function of the risk posed by the change.  Follow the results of your Risk Analysis for this change.  If it is very low it may be sufficient to confirm and document the appropriateness and robustness of the new software through performance testing of the device as a whole.

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    Paula Wilkerson RAC
    Sr. Engineer, Sr. Reviewer, Program Manager - Intertek Third Party Program
    Intertek
    Newberry FL
    United States
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    Original Message


  • 4.  RE:Validation for embedded software

    Posted 12-Dec-2012 11:17
    FDA's position is that if it can be programmed it meets the software definition and requires compliance with the regulations.  If you have a question, contact FDA through DSMICA at 1-800-638-2041 or 301-796-7100.  They will be happy to guide you or refer you to someone in the agency who can answer your question.  They are a great resource.

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    Edwin Bills RAC
    Principal Consultant
    Bilanx Consulting LLC
    Sumter SC
    United States
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    Original Message


  • 5.  RE:Validation for embedded software

    Posted 12-Dec-2012 15:02
    I agree with the prior replies that the firmware must be validated as software.  Two related FDA guidance documents that may be of assistance are

    'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices' (issued May 11, 2005)

    and

    'General Principles of Software Validation; Final Guidance for Industry and FDA Staff' (issued January 11, 2002).

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    Bryan Chojnowski RAC
    Denver CO
    United States
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    Original Message