Regulatory Open Forum

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  • 1.  Animal testing in medical devices

    This message was posted by a user wishing to remain anonymous
    Posted 6 days ago
    This message was posted by a user wishing to remain anonymous

    Hi everyone,

    I'm looking for some opinion about the need for animal testing.
    Is there any need to do biocompatible testing in animals in transvaginal probes which obviously are in contact with the intravaginal mucosa, but not directly because they may have a sheath covering them?
    Furthermore, I would also like to ask opinion about performing in vivo animal tissue studies to demonstrate this type of device's clinical safety.

    Thank you in advance and best regards,



  • 2.  RE: Animal testing in medical devices

    Posted 4 days ago
    Hi Anon

    Clearly for the sheath there will be a need for biocompatibility evaluation. For the probe, maybe. What is the risk that the sheath could be breached and leave the probe in contact with the patient?

    Decisions about in vivo animal tissue studies will be a matter of judgment - first the manufacturer's and then the regulator(s)' opinions. Ethically, it is important to avoid unnecessary animal studies, and there may be general agreement that such studies are unnecessary in the case of materials that have already been thoroughly studied.

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    Anne LeBlanc
    United States
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