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  • 1.  Substantial equivalence for technology differences

    This message was posted by a user wishing to remain anonymous
    Posted 12-Apr-2022 11:41
    This message was posted by a user wishing to remain anonymous

    Hello ,

    Needed advice on 510k substantial equivalence ; what happens when a difference in technological characteristics in the proposed device ( modified from the parent predicate device) , has concerns for safety and efficacy , does the FDA require the applicant to revert to the predicate device specifications or can they issue a NSE letter ?

    Thank you


  • 2.  RE: Substantial equivalence for technology differences

    Posted 13-Apr-2022 00:07
    Dear Anonymous,

    In accordance with FDA guidance when the information provided by the applicant is not sufficient to demonstrate substantial equivalence due to different technological characteristics resulting in additional concerns regarding safety- and performance-related matters, FDA generally first identifies the specific additional information – typically related to performance testing – that needs to be provided so that the FDA may complete its evaluation of substantial equivalence. Once the appropriate request has been received by the applicant, the applicant may provide additional information requested by the Agency. Should the applicant fail to provide such information or the appropriate justification (in case the information cannot be provided), the application will be considered incomplete and placed on hold. Moreover, should the delay in providing such information exceed the timeline specified in respective legislation, the application will be considered withdrawn. 

    It is up to the applicant to justify why the predicate device and the new product are substantially equivalent despite the safety and efficacy concerns. If you can't you will get a NDS letter from the FDA and have to go a different route De Novo or PMA route for clearance/market approval.

    Good luck,

    Dar

    ------------------------------
    Darlene Rosario MBA, RAC
    Principle Consultant
    Ventura CA
    United States
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    Original Message


  • 3.  RE: Substantial equivalence for technology differences

    Posted 13-Apr-2022 01:12
    I have seen this before and it could go both ways. The FDA could require clinical studies to be conducted, or they could want a simple 'test' to show equivalence. Is there a reason you changed the specifications in the new proposed device, and is it minimal risk to the patient?

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    Jessica Riggleman
    Newark DE
    United States
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    Original Message


  • 4.  RE: Substantial equivalence for technology differences

    This message was posted by a user wishing to remain anonymous
    Posted 13-Apr-2022 09:56
    This message was posted by a user wishing to remain anonymous

    Hi Darlene, Jessica,

    Thanks for your feedback, the specifications are revised to have a different method of achieving the intended use. However , is it possible if the FDA has concerns which cannot be backed up by sufficient clinical evidence , that we could revert to the original (predicate) specifications ?
    Original Message


  • 5.  RE: Substantial equivalence for technology differences

    Posted 15-Apr-2022 18:43
    If the method is "different" but characterizes the intended use, how would it result in different clinical evidence? If the safety and clinical evidence are of concern to FDA, I don't see how they could "deem" the device substantially equivalent to the predicate.  As indicated earlier, FDA will request additional information of help them determine substantial equivalence. Your company should be prepared to respond with data and support your position, otherwise you may need to consider a different approach to clearance/approval.

    Dar

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    Darlene Rosario MBA, RAC
    Principle Consultant
    Ventura CA
    United States
    ------------------------------

    Original Message


  • 6.  RE: Substantial equivalence for technology differences

    Posted 13-Apr-2022 09:49
    Not completely sure I understand your question - the parent device is cleared and can always be marketed under that clearance, regardless of the status of the newer device.

    That said, FDA can, and does, issue NSE letters when they think a product change raises new issues of safety and effectiveness - including, ironically, when the improvement actually improves safety. Often at that point they ask for additional data, including clinical data.

    As for "reverting to previous specs" I think it would depend on the specific device. For instance, if mostly a software change, but new hardware is leading to new questions, then yes perhaps you could "revert" to the old hardware. But is some instances the "improved" feature itself (say a new size of the device) is what would raise questions and there may be no way to revert.

    I encourage you to assess your specific case and see if there is a solution that gets you part of what you want that FDA will accept without a bunch of new data - often it can be done, but not always.

    Ginger

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    Ginger Glaser RAC
    Chief Technology Officer
    MN
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    Original Message


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