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  • 1.  Suggestion requested:Steps after 510k NSE decision

    This message was posted by a user wishing to remain anonymous
    Posted 23-Nov-2020 09:12
    This message was posted by a user wishing to remain anonymous

    Has anyone had clarification call with FDA after a NSE decision? Any recommendation on how to proceed ahead with it? Also any recommendation on Substantive summary report? What is general view on requesting for it? What is the proposed next step with new regulatory submission preparation?



  • 2.  RE: Suggestion requested:Steps after 510k NSE decision

    Posted 27-Nov-2020 02:47
    Hello,

    You should consider requesting a FDA pre-sub meeting as quickly as you can! Most companies avoid to submit a pre-sub meeting request, because of the time pressure and the pre-sub timelines (75-90) days. However, 75-90 days is not as costly for a company as receiving a second NSE letter.
    As preparation for your FDA pre-sub meeting you should of course analize what is the cause of your NSE letter. There can be multiple root causes that can cause a NSE decision such as failing to verify that the predicate is a legally marketed device, failing to evaluate the substantial equivalence of your device's intended use with the predicate, failing to convince FDA that the technological differences between the subject and predicate device do not raise different questions of safety and effectiveness or failing to provide data demonstrating equivalence.
    Once you have identified the root cause that triggered the NSE decision for your submission, make a plan to correct those deficiencies in your next 510(k) submission and then plan a pre-sub meeting with FDA with specific questions on aspects you consider essential to give you the confidence that the data provided in the next 510(k) is acceptable for FDA. Last thing you want is to get a second NSE therefore a pre-sub is an excellent tool you should use wisely to avoid that. See more about FDA guidance on pre-sub meetings:
    https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-medical-device-submissions-q-submission-program


    Kind Regards,



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    Ioana Ulea
    Regulatory Affairs Professional
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    Original Message


  • 3.  RE: Suggestion requested:Steps after 510k NSE decision

    This message was posted by a user wishing to remain anonymous
    Posted 30-Nov-2020 09:06
    This message was posted by a user wishing to remain anonymous

    I am only familiar with clarification calls after an Additional Information (AI) request, during the review. So just double check you have received a Not-Substantially Equivalent (NSE), not an AI. If a clarification call with the reviewer is indeed offered, I'd request it and just listen to them out about wall the reasons. HOWEVER, scheduling these calls can take time, and you may not get all the answers you want, so do not delay preparing the pre-sub meeting request/package.

    As far as Substantial Equivalence, as recommended by the guidance, it is first lists the predicate device, product code, and regulation number. Then it has as table that compares the key characteristics, very similar to what you can find in a 510(k) summary that is public on the FDAs website.
    Original Message


  • 4.  RE: Suggestion requested:Steps after 510k NSE decision

    Posted 30-Nov-2020 14:38

    If a Sponsor of a section 510(k) Notification receives a Not Substantially Equivalent (NSE) determination from the FDA, then in order to appropriately know the path forward, it is vital to understand the agency's motives for making the NSE decision.  Specifically, by statute, FDA will generally issue an NSE decision for two reasons:

    1. There is an unprecedented attribute(s) associated with the subject device.


    Examples include, but may not be limited to, things like a new intended use, absence of a suitable predicate device, or technological characteristics that raise new or different questions of safety or effectiveness with respect to the predicate device.  In this kind of scenario, FDA is generally required to automatically classify the subject device into Class III, consequently requiring either a Premarket Approval Application (PMA) or a section 513(f)(2) de novo classification in order to achieve legal marketing authorization.  If FDA believes the de novo route may be a viable option, then FDA will generally provide a corresponding hint in the NSE letter.

     
    2. The Sponsor simply did not provide sufficient information/evidence to demonstrate substantial equivalence compared to the predicate device.

    In this scenario (notwithstanding an appeal campaign), the NSE decision essentially terminates the corresponding 510(k) Notification, consequently requiring submission of a new 510(k) in order for FDA and the Sponsor to continue pursuit of the substantial equivalence determination for the subject device.


    Hope this helps,



    ------------------------------
    Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
    Principal Consultant
    ComplianceAcuity, Inc.
    Ridgway, CO
    United States
    www.complianceacuity.com
    © Copyright 2020 by ComplianceAcuity, Inc. All rights reserved.
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    Original Message


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