Regulatory Open Forum

 View Only
  • 1.  appeal of a 510(k) deletion

    Posted 14-Feb-2020 14:18
    Has anyone ever had a meeting with the FDA following an appeal of a deletion of a 510(k). In this case the requested additional information was 
    late two days. The submitter appealed the deletion and the FDA scheduled a meeting.

    ------------------------------
    John Samorajczyk
    Samorajczyk Regulatory Consultants, LLC
    St Pete Beach FL
    United States
    ------------------------------


  • 2.  RE: appeal of a 510(k) deletion

    Posted 17-Feb-2020 09:10
    From your description, it sounds like an "AI Response" was provided on the 182nd day. In this case, the submission is automatically withdrawn by the system and there is nothing the FDA can do to prevent the withdrawal. It has even happened to companies that were not aware of postal holidays and winter weather that prevented their submission from being delivered on-time. You will need to create a new 510(k) submission (including paying a new user fee), reference the previous submission, and make sure that you address all of the AI request issues in your new submission. The good news is that most of these submissions are reviewed more quickly than a new submission. In fact, I know of one company that completed the entire review in 8 days.

    ------------------------------
    Rob Packard
    Shrewsbury VT
    United States
    ------------------------------



  • 3.  RE: appeal of a 510(k) deletion

    Posted 20-Feb-2020 09:35
    I would be interested to know if FDA has ever let someone slide on one of its deadlines to correct deficiencies in a submission.  I was taught that they were set in stone, and, whenever the subject came up among colleagues, everyone else seemed to have been taught the same...miss the deadline, submission withdrawn, period, so I've never known of a situation in which someone missed one. 

    If I go with the common wisdom, I would give up on the notion that the meeting was for the purpose of appealing the deletion, and I would treat it as a pre-sub.  I'd take advantage of the opportunity to confirm that what I had been planning to submit as a response will be sufficient to address all of the remaining deficiencies when I include it in the new 510(k).

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------