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  • 1.  Animal testing and eSTAR

    This message was posted by a user wishing to remain anonymous
    Posted 30 days ago
    This message was posted by a user wishing to remain anonymous

    If the only animal testing is for biocompatibility, do you complete the animal testing section of eSTAR or mark this as no?



  • 2.  RE: Animal testing and eSTAR

    Posted 29 days ago

    Anon,

    It would be marked no.  Animal testing for biocompatibility is understood to be part of this testing and not a separate type of animal testing.  If you read back through the compilation of 510(k) on FDA's website, there is a brief explanation about animal testing which would be using animal models for performance testing (and usually safety) of the finished medical device.  Biocompatibility testing generally falls under this specific topic and even including this in the animal testing section might cause more confusion then leaving it only as part of biocompatibility.



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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Principal Strategy Consultant
    NAMSA
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    Original Message


  • 3.  RE: Animal testing and eSTAR

    Posted 29 days ago

    Hi Anon,

    I agree with Richard: Biocompatibility has its own section in the eSTAR template and the section you refer to is probably the one under the general section "Performance Testing". So putting "yes" here for standard biocompatibility animal tests would probably lead to confusion.

    Best regards, Christoph



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    Christoph Kiesselbach
    Schrack & Partner
    Reutlingen
    Germany
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    Original Message


  • 4.  RE: Animal testing and eSTAR

    Posted 29 days ago

    We mentioned the animal testing briefly in the biocompatibility section, and completed the Animal Testing section.



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    William Coulston PMP, MS, RAC
    Director of Quality & Regulatory Affairs
    Rochal Technologies
    San Antonio TX
    United States
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    Original Message


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