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  • 1.  FDA Third Party Review

    Posted 10-Jul-2022 02:13

    Dear Colleagues,

     

    Please detail your experience with 510k third-party review compared with a standard FDA review.

     

    Thank you,

     

    Yoram

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  • 2.  RE: FDA Third Party Review

    Posted 11-Jul-2022 03:03
    Hello Yoram,

    I am a former FDA 3rd Party reviewer. The overall goal of the program is to allow 3rd parties to review your 510(k)'s and create deficiencies just as the FDA would do. One benefit is that 3rd parties work with clients to determine the substantial equivalence, safety and effectiveness, which may take more than  one or two rounds with the client. Once the 3rd party is finished they create an internal report to the FDA. That internal report should take no more than 30 day for the FDA to review and come up with a final determination.

    Also not you are not required to pay an FDA user fee if you use a 3rd party.

    ------------------------------
    James W. Monroe, MS, RAC, CQA
    President & CEO
    Global RQC Med Device Solutions, LLC.
    Somerset, NJ
    USA
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    Original Message


  • 3.  RE: FDA Third Party Review

    Posted 11-Jul-2022 11:39
    Hello Yoram,

    We have used an FDA 3rd Party reviewer 3 times in the past year and have been very happy with the results in both cost, support (as James states, they are very supportive and interactive), and overall time. In fact, one just had a traditional 510(k) cleared in 42 calendar days! I would recommend a 3rd Party reviewer as an alternate to traditionally working with the FDA directly.

    ------------------------------
    Adam Black
    Regulatory Affairs Manager
    South Jordan UT
    United States
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    Original Message


  • 4.  RE: FDA Third Party Review

    Posted 12-Jul-2022 01:23
    Thank you very much for your responses.
    They are informative and beneficial.

    Yoram

    ------------------------------
    [Yoram] [Levy]
    [General Manager]
    [Qsite]
    [Binyamina]
    [Israel]
    ------------------------------

    Original Message


  • 5.  RE: FDA Third Party Review

    This message was posted by a user wishing to remain anonymous
    Posted 12-Jul-2022 09:35
    This message was posted by a user wishing to remain anonymous

    Can you let me know which one did you choose ?

    thanks,
    Original Message


  • 6.  RE: FDA Third Party Review

    This message was posted by a user wishing to remain anonymous
    Posted 12-Jul-2022 09:27
    This message was posted by a user wishing to remain anonymous

    I had an unfortunate experience with one; I posted about it earlier today. I was interested to see that one commenter indicated they might need more than 3 rounds. Our reviewer gave up on giving us advice after the 3rd round. We were not arguing with them or being unprofessional but the reviewer decided to stop, and refused to tell us what was left to add to the submission to meet their needs.
    Original Message


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