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  • 1.  Model numbers /Trade name changes

    This message was posted by a user wishing to remain anonymous
    Posted 30-Nov-2020 09:06
    This message was posted by a user wishing to remain anonymous

    Hi,

     

    With design changes for existing devices (class II), is there any advantage of retaining the existing trade name or model number  for approved devices or is it easier to manage such changes through adoption of new device names?

     Thanks



  • 2.  RE: Model numbers /Trade name changes

    Posted 01-Dec-2020 06:54
    Hello Anon,

    Well there are many reasons to keep the trade name/model numbers when making a design change ... and also many reasons to not keep.  This would need to be determined based on the device type, market of the device, what type of design change is being made.  Your question is a bit broad for answering, so would need to evaluate different aspects to determine if a trade name or model number change would be appropriate or not.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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