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  • 1.  Pre-submission question

    Posted 15-Mar-2018 02:24
    Edited by Jinali Bhavsar 15-Mar-2018 02:35
    Hello,
    I would like to know if one can submit a Q-sub for submission issue meeting to address the deficiencies received for 510k substantive review without agenda or specific questions.Can you request for the Q-sub saying that agenda and slides will be provided in 10 days advance of the scheduled meeting.
    Thank you

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    Jinali Bhavsar RAC
    Regulatory Affairs Specialist
    Santa Clara CA
    United States
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  • 2.  RE: Pre-submission question

    Posted 16-Mar-2018 09:43
    Jinali,

    In theory you could do that, but in practice I have not seen that done.  Even during a Q-Submission Submission Issue meeting request - addressing deficiencies in the 510(k) - they still want to see a formal request with your questions or statements related to the submission.  This gives them time to prepare by reviewing your concerns, your position against theirs, or additional information provided.  Already the Submission Issue meeting target is 21 days, so providing them an agenda or list of topics 10 days prior to the meeting would not bode well.  In fact, I did experience this once (I was just on the team) that we requested a 510(k) Submission Issue meeting, we were still hammering out internal what the issues where.  During the actual Submission Issue meeting it went very poorly because the FDA basically said, 'We can not comment' or 'Please read the AI request letter' because we were not prepared, everything was open-ended, and the FDA gave us no feedback worthwhile.  Needless to say, there was still no direction, so ended up withdrawing the submission and starting again.  Be prepared in advance is best advice.

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    Richard Vincins RAC
    Vice President Regulatory Affairs
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    Original Message


  • 3.  RE: Pre-submission question

    Posted 17-Mar-2018 15:15

    I assume you have read the wording in the guidance at least 10 times by now:

    • a proposed agenda describing the deficiencies for discussion and the estimated time for each agenda item;

    I don't think FDA really means "describing" in the first bullet point.  FDA wrote the deficiencies, after all, so it doesn't need you to describe them.  I think it probably means "identify."  To be on the safe side, I'd cite the entire deficiency, not just whatever number it was assigned in the deficiency letter.  (Maybe that's what FDA meant by "describe."). But I would also include the number, so FDA can find it easily in the deficiency letter, if it should want to go looking for it.

    • focused questions for which you are seeking guidance from FDA, if applicable.

    Don't you just love "if applicable"?  I would take this to mean "if you have focused questions," not that there are circumstances in which you must have focused questions.  However, the fact that I would take it this way doesn't mean that's how FDA meant it.

    I will assume you are on the clock for responding to the deficiencies, and that your concern is that, by the time you have a chance to carefully analyze the deficiencies and potential ways to address them, and then get into a meeting, you won't have much time left after the meeting to address the deficiencies, especially if it might be necessary to collect some more data.  I expect FDA knows this too, and is likely to provide a bit more flexibility under these circumstances than for something like a pre-sub.

    Or maybe the company is a startup that is going to lose its investors if it can't persuade them that it can answer the deficiencies, and/or provide them with a reliable cost estimate to do so, and soon.

    Regardless, I would contact your lead reviewer, tell them why you would like to do it this way, and see what they say.  I can't promise that you'll get the answer that the company wants, but you will get the answer that counts, which is FDA's, not ours. (This is not a situation in which I would try to pursue forgiveness over permission, but that's me.)



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


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