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  • 1.  biocompatibility materials from different industry

    This message was posted by a user wishing to remain anonymous
    Posted 27-Sep-2019 09:49
    This message was posted by a user wishing to remain anonymous

    Hi, 
    I wonder if any of you has experience with the FDA's thinking on the use of materials (e.g., coating, varnish, etc.) used in aircraft or automobile industry for limited or prolonged skin contact. Which type of evidence on biocompatibility from the supplier - to be included in our risk assessment -could be deemed satisfactory? Could a justification based on history of safe use of this type of material in contact with people be sufficient?


  • 2.  RE: biocompatibility materials from different industry

    Posted 27-Sep-2019 17:35

     

     

    Hi Anonymous,

     

    I'm not immediately seeing how prior use of the materials in the aircraft and auto industry per se would have any bearing on biological evaluation of their use in medical devices, though I infer there may have been types of contact with humans in those applications that would be similar to the medical device use case.

     

    Assuming this is correct, the history of use may be supportive--but it's unlikely to be sufficient.  The same would be true for any biological test data the supplier may be willing to provide.  There are at least a couple of reasons for this;  primary being that FDA (and most regulators) expect the biological evaluation to be done for the final, finished device.  Manufacturing and processing of the materials often plays a role in their biocompatibility.

     

    A secondary reason that history of use is not likely to be sufficient is that there may have been changes in composition/formulation of the materials over the years--demonstrating that this is not the case is often difficult to impossible.

     

    I hope this is helpful.  Please feel to contact me directly if you would like more guidance.  I've been part of TC 194 (the technical committee for ISO 10993) for over a decade.  Contact info is in my signature block.

     

    Best regards,

     

    Ted

     

    --

    Theodore (Ted) Heise, PHD, RAC

    Vice President Regulatory and Clinical Services

     

    MED Institute Inc.

    1330 Win Hentschel Blvd.

    West Lafayette, IN  47906-4149 USA

    765.463.1633 ext. 4444

    http://medinstitute.com

    theise@medinstitute.com

     

     

     

     

     

     




    Original Message


  • 3.  RE: biocompatibility materials from different industry

    Posted 30-Sep-2019 09:34
    Of my understanding when you look through ISO 10993 - using a risk based approach - any material used in medical devices needs to "stand on its on" regardless whether used in other industries.  Unfortunately not all FDA reviewers and certainly not consistent across CDRH on the application of risk based approach with biocompatibility.  As an example, I had instances where materials where used in short contact, i.e. a tonometer type of device where patient puts their chin on a chinrest, which I completely described the material.  I also showed the materials used in many other industrial and commercial applications.  Sadly, the FDA reviewer still wanted biocomp testing performed.  So just in my experience along, because a device is used in other industries does not preclude FDA from requiring testing - there are a couple other threads on this issues.  (Can only wish FDA would use some common sense so we did not have to hurt poor little rabbits !)

    ------------------------------
    Richard Vincins RAC
    Vice President Global Regulatory Affairs
    ------------------------------

    Original Message


  • 4.  RE: biocompatibility materials from different industry

    Posted 01-Oct-2019 10:03

    You might be interested in this FDA webpage to get answers to your questions. Just published today. 

    https://www.fda.gov/medical-devices/products-and-medical-procedures/metals-used-medical-devices?utm_campaign=2019-10-01%20CDRH%20New&utm_medium=email&utm_source=Eloqua#determining 

    Note that FDA recognizes ISO 10993-1 to give guidance on required biocompatibility testing. 



    ------------------------------
    Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
    Principal Consultant
    Overland Park KS
    United States
    elb@edwinbillsconsultant.com
    ------------------------------

    Original Message


  • 5.  RE: biocompatibility materials from different industry

    Posted 01-Oct-2019 11:05
    Remember that when considering such retrospective equivalency assertions, FDA typically demands that the proposed retro alternative use-case(s) involve the same materials, with the same intended medical use (including, but not limited to, the same nature and duration of medical/therapeutic contact in the same or similar parts of the human body), and processed in the same way.  So in my experience, FDA would most certainly reject the aircraft/automobile industry uses outright simply because those don't involve clinical/therapeutic use of the materials.

    ------------------------------
    Kevin Randall, ASQ CQA, RAC (U.S., Canada, Europe)
    Principal Consultant
    ComplianceAcuity, Inc.
    Golden CO
    United States
    www.complianceacuity.com
    ------------------------------

    Original Message


  • 6.  RE: biocompatibility materials from different industry

    This message was posted by a user wishing to remain anonymous
    Posted 01-Oct-2019 14:40
    This message was posted by a user wishing to remain anonymous

    Thank you all for your insights. 
    Best,
    Original Message


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