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  • 1.  FDA Pre-submission for a new device

    This message was posted by a user wishing to remain anonymous
    Posted 5 days ago
    This message was posted by a user wishing to remain anonymous

    Hello,

    For a new device in the final stages of development, where the classification is not clear nor the clinical pathway, what should the first pre-sub address ?  How many topics can the pre-sub cover ? 



  • 2.  RE: FDA Pre-submission for a new device

    Posted 4 days ago

    Is there a device description and proposed intended use? you can propose the pathway to the FDA.



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    Edward Panek
    VP, QA/RA
    Med Device
    USN Veteran
    Research into Neural Nets - https://www.twitch.tv/edosani
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  • 3.  RE: FDA Pre-submission for a new device

    This message was posted by a user wishing to remain anonymous
    Posted 4 days ago
    This message was posted by a user wishing to remain anonymous

    Hi Ed,

    I wanted to know if it is possible to request feedback on the risk classification, clinical protocol for IDE and the submission pathway in one pre-sub?




  • 4.  RE: FDA Pre-submission for a new device

    This message was posted by a user wishing to remain anonymous
    Posted 3 days ago
    This message was posted by a user wishing to remain anonymous

    For risk classification feedback, submit a 513(g) which has a user fee of $2,980 for a small business and $5,961 for a standard fee. Even though I have seen FDA provide feedback to a Pre-Sub regarding classification. The clinical protocol can be submitted as an attachment to the Pre-Sub. Within the Pre-Sub should have specific questions regarding the clinical protocol for FDA's feedback and concurrence. If the clinical protocol is effective, it can be revised based on FDA's pertinent feedback. For feedback on the regulatory pathway, provide a proposal in the Pre-Sub with specific questions for FDA's feedback.




  • 5.  RE: FDA Pre-submission for a new device

    This message was posted by a user wishing to remain anonymous
    Posted 4 days ago
    This message was posted by a user wishing to remain anonymous

    The first Pre-Sub should address the verification and validation study proposals (analytical and clinical) for FDA's feedback and concurrence as well as the proposed regulatory pathway (if planning for a future 510(k), a proposed predicate). It is recommended by FDA in their Q-Sub Program guidance document to target three to four substantial topics to allow sufficient FDA review time.

    A link to the Q-Sub Program guidance document:
    https://www.fda.gov/media/114034/download




  • 6.  RE: FDA Pre-submission for a new device

    Posted 3 days ago

    Providing more information about the device would be beneficial in providing an accurate response. If the classification and submission pathway are not clear, you really need to start there because without that information you cannot adequately setup the clinical protocol for IDE. I suspect you have an idea of the classification and submission pathway but maybe are torn between a few different options. It is in your best interest to make an argument for the one which fits best and is the least burdensome and see what the FDA has to say about it in your initial pre-submission.

    Feel free to reach out directly for additional assistance. 



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    Wade Munsch
    Regulatory Affairs Manager
    Biotex, Inc.
    Houston TX
    United States
    Company Website: www.biotexmedical.com
    Test Lab Website: https://www.biotexmedical.com/criterion/
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  • 7.  RE: FDA Pre-submission for a new device

    Posted 3 days ago

    I wanted to echo what others have said. The purpose of a pre-submission is to get feedback from FDA on your planned submission. I'd highly suggest putting together the best proposed regulatory strategy you can and asking FDA in the pre-sub if they concur. If you ask FDA what they believe the classification etc. should be they will likely respond that you should submit a 513(g) request which does have a fee associated with it. FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act | FDA

    In the first pre-submission, I think it is reasonable to expect that you could get clarity on what submission type FDA will require for your device and what type of validation data is likely to be required. If it is evident that a clinical trial would be required I would plan to have a pre-sub supplement to discuss the protocol with FDA. 



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    Michelle Hasse
    Elkhart IN
    United States
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  • 8.  RE: FDA Pre-submission for a new device

    Posted 3 days ago

    First step would be to come up with the intended use, description and submit a  513(g) Request  with FDA, this is specifically for classification request. it is advisable to utilize that and then work on the risk management, IDE, clinical pathway. Presubs recommendation by FDA is 3-4 substantial topics per meeting. If the topics are more than recommended FDA will come back to you to focus on more important ones. 



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    Raje Devanathan
    Amerisource Bergen
    TPIreg, Innomar Strategies
    Senior Manager - Regulatory Affairs, Medical Devices
    rdevanathan@tpireg.com
    3470 Superior Court
    Oakville ON L6L0C4
    Canada
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  • 9.  RE: FDA Pre-submission for a new device

    This message was posted by a user wishing to remain anonymous
    Posted 2 days ago
    This message was posted by a user wishing to remain anonymous

    Does Classification influence the IDE ?




  • 10.  RE: FDA Pre-submission for a new device

    Posted 2 days ago

    It definitely would. A lower class device will have less of a burden to show it can be used in humans than a higher class device. Additionally, if you have a predicate that will set the minimum bar for your study design because you have to show substantial equivalence. If your device is De Novo, then you would have much more flexibility in the study design but it still depends on other available interventions. You really need to be sure you do not have a predicate, then lock down the classification before attempting to submit and IDE.



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    Wade Munsch
    Regulatory Affairs Manager
    Biotex, Inc.
    Houston TX
    United States
    Company Website: www.biotexmedical.com
    Test Lab Website: https://www.biotexmedical.com/criterion/
    ------------------------------