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  • 1.  De Novo submission related query

    Posted 23-Aug-2022 18:02
    Dear RAPS community,

    Looking for some guidance with regards to a De Novo submission to the US FDA. We have a study that is in progress but won't be completed before the De Novo submission target date and one option that was being considered was to submit the De Novo with a formal commitment to the FDA with regards to the completion of that study i.e. we would state the estimated study completion date and the date by which the study report could be submitted to the FDA as a supplement to the initial submission. 

    It would be helpful to know if anyone in the community has either taken similar approach with their De Novo or is aware of any guidance on this topic. 

    Note: The pending study is not a critical study i.e. not a performance claim defining study.  

    Thank you very much for your help! 

    Best regards,
    Tejas

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    Tejas Kulkarni

    Canada
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  • 2.  RE: De Novo submission related query

    Posted 24-Aug-2022 02:56
    Greetings Tejas,

    When making a submission to US FDA, e.g. 510(k), PMA, De Novo, information contained in the submission needs to be complete.  There is no method to provide additional information once the submission has been made (the only kind of exception is a Modular PMA which is done in phases or PDP).  You can make a commitment, but honestly this really does not mean anything because reviewers need to examine the data, not something which is not available yet.  Recommend not making the De Novo submission until the study has been completed; FDA would not accept additional information in the future once the initial submission is made.  In fact, if the study is not complete the submission may not pass the Refuse to Accept process.  However, you do not want to approach FDA in this manner anyway, they do not like incomplete submissions.  If this is not a critical study contributing to safety or efficacy support, consider whether the information needs to be included or not.  But if including, definitely do not submit until the study is complete and the report can be included in the De Novo submission.

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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: De Novo submission related query

    Posted 24-Aug-2022 09:09
    All your clinical studies and any other type of applicable performance testing, e.g., biocompatibility, electrical/emc, mechanical/safety, software V&V, bench testing, etc., must be completed and included when you first submit. If it's not, the submission will be rejected during RTA review and the review will not proceed further.

    The main problem with the promise is that just because you plan on finishing a clinical study, does not mean it will yield the results you expect. I've seen many studies that ended up with results that do not support the claims the company was initially hoping to make. In best cases this maybe required a simple change to the intended use statement or a contraindication/warning statement, but in worst required significant modifications to the submission, a new study, or an entirely different approach.

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    Michael Zagorski RAC
    Director of Regulatory Affairs
    Pittsburgh PA
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    Original Message


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