Regulatory Open Forum

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  • 1.  Collagen as a Biologic

    Posted 16-May-2019 17:47
    Colleagues,

    I am trying to put a rumor to bed within my company concerning collagen products in the KGN product code being regulated by CBER versus CDRH.  I don't believe this to be true but am reaching out as part of my due diligence.  Has anyone heard anything long these lines?  

    Thanks,

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    William Coulston PMP, MS, RAC
    Quality & Regulatory Manager
    San Antonio TX
    United States
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  • 2.  RE: Collagen as a Biologic

    Posted 17-May-2019 03:39
    Hi!  I can confirm that animal detained KGN devices are regulated as class 2 510k.  PM new to discuss further if needed

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    Tina O'Brien RAC, MS
    Director of Regulatory Affairs
    Airport Oaks
    New Zealand
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    Original Message


  • 3.  RE: Collagen as a Biologic

    Posted 17-May-2019 08:31
    Hi William:

    Is this an animal derived or human derived collagen product?

    For animal derived, as long as you stay within the indications of a KGN wound management device the device will be reviewed by CDRH. However, if your company wants to make claims that have a biological mode of action, then the device may be reviewed by CBER. It should be noted that the KGN product code has a narrow definition and should not be sold or marketed as a skin substitute.  You can see at the below link that these products are currently reviewed by the surgical and infection control devices group.  

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=KGN

    The topic of human collagen products for wound management has had some press lately about how they are regulated. If this is the case- I can send you to some resources that may be of assistance.

    Hope this is helpful!

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    Andrea Pilon Artman, MS, CQE
    President & Principal Consultant
    SpectRA Compliance, LLC
    Frederick, MD
    USA
    andrea.artman@spectracompliancellc.com
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    Original Message


  • 4.  RE: Collagen as a Biologic

    Posted 17-May-2019 09:53
    I apologize for the confusion.  I really meant to ask is there a move afoot to switch the collagen products in the KGN product code from CDRH to CBER?  I completely agree with the current state of affairs, i.e. collagen as a Class II device consistent with the device definition.

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    William Coulston PMP, MS, RAC
    Quality & Regulatory Manager
    San Antonio TX
    United States
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    Original Message


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