Regulatory Open Forum

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  • 1.  Classification

    Posted 30-Nov-2017 12:41
    ​

    I hope all of you had a great TG and look forward to the New Year.

    There are many reclassification efforts underway, worldwide and I do have a question and appreciate any opinion and or experience you have.

     

    The scenario is that a previously 510(K) cleared device was reclassified by the FDA to a class III. Having clinical data for the device allows me to get the PMA approval in a reasonably manner. Continue with my design improvements, I planning to design a new device, identical "intended use", but much more advanced technology components and functions.

     

    I understand that with an existing PMA cleared device a PMA supplement would be sufficient and likely I need to file a full blown PMA but would like to know if my clinical data I have from the previous model is sufficient for the PMA application or should I consider a human trial?

     

    I hope my question is clear and understandable

     

    I look forward of your answers.

     

    Thanks,

     

    Armin



    ------------------------------
    Armin Beck
    CEO
    SunTrixConsulting LLC
    El Dorado Hills, CA
    1-925-212-7683
    armingbeck@aol.com
    ------------------------------


  • 2.  RE: Classification

    Posted 30-Nov-2017 14:34
    Hi Armin,

    While this is not my core field of expertise - I'll try to chip in. I think there is insufficient data in your question for a detailed answer anyway ;-)

    I see two distinct and separate issue to address:

    1) Why dit FDA reclassify your previously 510(K) cleared device to a class III device?

    2) Is the clinical data for your current device sufficient and adequate for your future device with identical "intended use", but much more advanced technology components and functions.

    Ad 1:
    I think the answer to this question may be important to understand before being fully able to address question 2.

    Ad 2:
    Indicating, that your future device will be much more advanced leads to the question: will your current device then be able to serve as a predicate device allowing for a PMA supplement, or is it a whole new ball-game?
    Although the topic is 510(K), I would recommend you listen to the podcast from greenlight.guru by John Speer and Michael Drues on the topic "Common Mistakes That Can Tank Your FDA 510(k) Submission". They have a great discussion on similar issues.

    ------------------------------
    Claus Rømer Andersen
    Rømer Consulting Aps
    Hørsholm, Denmark
    claus@roemerconsulting.dk
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    Original Message


  • 3.  RE: Classification

    Posted 01-Dec-2017 03:50
    Would agree with the second point that Claus makes that you have to consider that while the indications for use has not changed, does the advanced technological features impact the safety and efficacy.  Just remember that a PMA is not a 510(k), as such it must stand on its on.  If you are going to make a PMA Supplement, there are also various options on Supplements that can be chosen.

    While you can get all the advice and more from this forum which there are many experts, unless someone from the FDA responds specifically to your question, specific to your device, then that is all it would be ... advice.  My honest recommendation is that if you are really planning to do a Supplement, spend the time to have a Q-Sub meeting with FDA to state you are making change x, y, z, ... etc., and that you are not planning to perform new clinical trial data.  See if they agree with that, because ultimately do you want to take all of our advice (which may be great) but have to tell your CEO that now the Supplement is delayed for one year because need for more clinical data? Or do you want to spend 2 or 3 months to get feedback from FDA if they expect clinical data from changes to the device?

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    Richard Vincins RAC
    Vice President Regulatory Affairs
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    Original Message


  • 4.  RE: Classification

    Posted 01-Dec-2017 09:22
    Armin,

    I worked with a similar situation for many years. In general, we were very successful in using PMA Supplements for "next generation" versions of our device, and generally PMA Supplements that did not require clinical data. However, it is very important to understand both what concerns are causing FDA to up-classify the device in the first place, and "how different" your updated devices are.

    For instance, in one of our cases, the FDA's big concern in updating was silicone implant issues. Once we had the original PMA, we were able to make many changes in shapes, internal materials, reliability etc via PMAS with no clinical data. However, changes that, for instance, were changing sizes to be used in younger/smaller patients were PMAS with clinical data. And finally, changing the "functions" of the device from being operated manually to remotely and electronically triggered a new PMA.

    I'd encourage you to make your case for a "straight PMAS" and run it by your review branch for a bit more certainty. I am sure they will tell you to do a pre-sub (they always do these days) but you should be able to get an answer.

    g-

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    Ginger Glaser RAC
    Chief Technology Officer
    MN
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    Original Message


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