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  • 1.  DeNovo Pre-Submission

    Posted 28-Nov-2019 06:45

    Hi All.

    I will be looking to submit a pre-sub in the New Year for a De Novo application and was wondering whether anyone had experience with this? From what I understand, the pre-sub process is the same as for a 510(k) Are there more specific points that the FDA would like to see you cover?

    Any advice is welcome.

    Thanks

    James



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    James
    Head of QARA
    UK
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  • 2.  RE: DeNovo Pre-Submission

    Posted 29-Nov-2019 05:45
    James,

    It really depends on what you want to get out of the pre-sub (Q-Submission) process for the De Novo application.  I would not say it is the same as 510(k) process because every Q-Sub request is different depending on what feedback you are trying to achieve from the FDA.  As an example, Q-Subs are used to get feedback from FDA on performance testing, comparative testing, usability testing, clinical testing, confirm regulatory pathways, confirm claims/indications for use, etc.  If you are submitting a Q-Sub for a De Novo application, it depends on what you are trying to get out of this submission, not what FDA would like to see covered.  The advice I would give for any Q-Sub request is you tell FDA your strategy, tell them your testing plans, tell them your clinical protocols, and then ask if they agree.  Going into a Q-Sub meeting De Novo or 510(k) asking open ended questions is really not going to give you good feedback.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: DeNovo Pre-Submission

    Posted 29-Nov-2019 09:41
    Thanks Richard. 

    The feedback we will want to receive will be around the test approach, all aspects of it! Our first pre-sub (510(k)) was fairly lightweight due to the simplicity of the device, the De Novo.... not so! We will have quite a few documents to write and phrasing the questions well is going to be so important as like you say, we do not want these to be open-ended!

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    James
    Head of QARA
    UK
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    Original Message


  • 4.  RE: DeNovo Pre-Submission

    Posted 02-Dec-2019 15:10
    I second Richard. Draft a concrete, thorough V&V testing plan supported by clinical evaluation data and risk management files, and ask specific questions that can lead you to a simple yes and no instead of obtaining high-level feedback which won't serve you any good.  When considering De NOVO, we have another option, that is, you can submit a 510(k) and upon receipt of an NSE determination, the De NOVO request can be made. If FDA denies De NOVO, you would have the option of filing PMA. Good luck.

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    Jo Huang RAC
    Sr. Regulatory Affairs Specialist
    Athens TX
    United States
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    Original Message


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