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  • 1.  Usability (HF) study submitted as part of 510(k)

    Posted 13-Feb-2014 06:22

    When submitting (in a 510k) the results of a Human Factors (Usability) study performed in the USA on a medical device, should we submit only:
     - the blank questionnaire and

     - the study protocol and

     - the summary report; OR

    should we ALSO SUBMIT the HF     questionnaire as completed by each study participant?



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    Asher Kassel
    Lifewatch Technologies Ltd.
    Rehovot
    Israel
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  • 2.  RE:Usability (HF) study submitted as part of 510(k)

    Posted 14-Feb-2014 10:09
    For a 510(k) submission, for which you are including study documentation, submitting a copy of the questionnaire, the protocol and the study summary should be sufficient. 

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    Michael Tomasovich
    Director Business Development
    Regulatory Affairs Associates
    Inkster MI
    United States
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    Original Message


  • 3.  RE:Usability (HF) study submitted as part of 510(k)

    Posted 17-Feb-2014 11:28
    Asher,

    Like other V&V reports you need only submit the protocol (which should contain the questionnaire template), the report summarizing the data and the data - which is a compilation of the responses.  The data would be al listing of the responses.  You do not need to submit each completed questionnaire but should of course have them on hand with your final report internally.

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    Peggy McLaughlin
    Menlo Park CA
    United States
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    Original Message