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  • 1.  510k Review Cycles

    This message was posted by a user wishing to remain anonymous
    Posted 15-Apr-2019 20:30
    This message was posted by a user wishing to remain anonymous

    Is there a maximum number of review cycles that FDA is willing to endure?
    Thanks.


  • 2.  RE: 510k Review Cycles

    Posted 16-Apr-2019 04:54
    There are only 2 according to MDUFA which they need to keep their metrics for budgeting and turnaround.  The first one is the Refuse to Accept (RTA) where the reviewer performs the administrative review; the submission is put On Hold for 180 days.  After the RTA is accepted, then the reviewer completes the substantive review.  If additional items are found then there is a request for Additional Information (AI); the submission is put On Hold for 180 days.  Based on the response to the AI if there are minor things the reviewer finds, or clarification, then they perform an interactive review.  In conclusion there are basically 2 rounds where additional information is requested - if never of these are met then the submission needs to be withdrawn, cancelled, or SE/NSE letter issued.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: 510k Review Cycles

    Posted 16-Apr-2019 09:54
    One important piece of information, once in substantive review the Agency can only put your submission on hold once.  


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    William Coulston PMP, MS, RAC
    Quality & Regulatory Manager
    San Antonio TX
    United States
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    Original Message


  • 4.  RE: 510k Review Cycles

    Posted 16-Apr-2019 16:37
    Yes-- three strikes and you are out, meaning if FDA still has issues or questions after the 3rd round of additional information requests, you will receive a NSE letter. Granted you can ask for a conference call with the reviewer after the NSE notification and get clarification on what you need to do for the submission to be successful when you re-submit, but you should have engaged the review team via the Submission Issue Request venue if there is anything in the first AI letter that you don't understand so that you don't receive the 2nd or 3rd AI letters.


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    Thomas Lawson PhD
    Principal Consultant
    El Cerrito CA
    United States
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    Original Message


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