Regulatory Open Forum

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  • 1.  Growth Factor in Animal Tissues/ Medicinal Product

    Posted 17-Nov-2021 05:07
    Hello Friends - I have a question about growth hormones/ growth factors which are naturally present in the Animal tissues. Our product uses  animal tissue which has growth factors and it is applied on the human body and is absorbed by the human body locally.

    For complying with MDR 2017/245, do we have to consider this to be a medicinal product? I was inclining towards not calling it a medicinal product as there is no drug component involved with this device. And, the growth factors present in the animal tissue is naturally occurring.

    Appreciate your feedback.

    Thanks and Regards,

    Karthik Natesan, RAC

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    Karthik Natesan, RAC
    KN Consulting and Services
    (Quality and Regulatory Consultant)
    Newark, DE
    P: 949-245-5607
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  • 2.  RE: Growth Factor in Animal Tissues/ Medicinal Product

    Posted 18-Nov-2021 08:24
    Hi Karthik,

    Look up a company call Cook Biotech.  They use a porcine SIS graft and are not considered medicinal product.  It also depends on your indication, application and your claims etc.  There is enough information about them out there as well as on FDA 510(k) summary info about their products.  They also have a USP for SIS which states the growth factors that are present.

    thanks

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    Niraj Ramachandran
    Director Regulatory - CMC
    Cambridge MA
    United States
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  • 3.  RE: Growth Factor in Animal Tissues/ Medicinal Product

    Posted 18-Nov-2021 08:52

    Thanks a lot for your feedback Niraj! Will look into Cook Biotech's Porcine SIS graft.

    Best Regards,

    Karthik



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    Karthik Natesan, RAC
    KN Consulting and Services
    (Quality and Regulatory Consultant)
    Newark, DE
    P: 949-245-5607
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  • 4.  RE: Growth Factor in Animal Tissues/ Medicinal Product

    Posted 18-Nov-2021 17:56
    Edited by Arthur Brandwood 18-Nov-2021 18:04
    Hi Karthik,

    I am assuming the primary purpose of the product is as a device (you don't state what it is).

    However if the therapeutic action is primarily as a result of the growth factors influencing the tissue then you would have a medicine.  This debate went on for some time when freeze dried bone grafts were first introduced.  There was an argument that the bone chips were primarily acting as a vehicle for the growth factors to promote bone regrowth and that the physical scaffolding was a secondary effect so they should be medicines.  In the end, the argument for a device (primarily a physical scaffold supported by ancillary action of growth factors) won out in most jurisdictions.

    But if you have a medical device you still need to be very careful.  The definitions in the MDR are based on the presence of a substance which could be considered a medicine and which acts on the body.  It appears possible that this is the case here, in which case you would have a Class III device and need to follow the additional parts of the MDR which deal with the presence of medicinal substances.

    My experience is that European Competent Authorities (especially in Germany)have for a few years now been taking a more conservative approach on devices containing active substances, which has caused a number of products to be reclassified and subject to reassessments by the Notified Body.

    I suggest talking to your Notified Body about this and get clarity on their view.

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    Arthur Brandwood PhD FRAPS
    Sydney, Australia
    Arthur.Brandwood@gmail.com
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