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  • 1.  510k Cleared Device Importing/Private Label

    Posted 04-Nov-2017 01:01

    Hello All,

    I had a few questions regarding importing a class II device into the US. I would appreciate if you could help me with this. 

    My company would like to import a Class II 510K cleared device into the US. I know that we as initial imported will have to register, follow MDR etc.

    But my questions are specific to the device itself

    1. Can we replace the brand name of the device with our Corporate name and leave the entire label as is? 
    2. If yes, where does the <g class="gr_ gr_770 gr-alert gr_gramm gr_inline_cards gr_run_anim Grammar multiReplace" id="770" data-gr-id="770">manufacturers</g> information go? Does it have to say "Manufactured by XYZ" and "Manufactured for ABC" and include my <g class="gr_ gr_1078 gr-alert gr_gramm gr_inline_cards gr_run_anim Grammar multiReplace" id="1078" data-gr-id="1078">companys</g> information for complaint handling?
    3.If no, then how can we add our logo to the label? Again, no other changes will be done to the original label

    The label is basically on an overwrap with Indications for use and Directions for use. 

    I would really appreciate your help

    Thanks
    Raza



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    Raza Mohammed
    Regulatory Affairs Manager
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  • 2.  RE: 510k Cleared Device Importing/Private Label

    Posted 06-Nov-2017 10:32
    Hi,
    Few points to consider:
    • Under 21 CFR. Part 807 Private label distributors are not considered as  "manufacturers"; the information that should be on the label appears in 21 CFR part 801.1 section c.
    • If the ONLY change you apply to the original labeling is ADDING your company name you are NOT considered as a <g class="gr_ gr_1194 gr-alert gr_spell gr_inline_cards gr_run_anim ContextualSpelling" id="1194" data-gr-id="1194">relabeler</g>, else you are and the registration requirements would apply to you.
    • You need to consider the labeler definition in the UDI regulation, you might need to comply with the UDI rule as a labeler. 
    • Last but not least you should make sure that you have all the right QA agreements in place.
    You can try to further look into it by contacting the FDA registration and listing helpdesk and the UDI helpdesk.
    Regards
    Tal
      

    ------------------------------
    Tal Bresler, PhD.RAC

    Toronto, On, Canada
    tal.bresler@gmail.com
    https://www.linkedin.com/in/talbresler/
    ------------------------------

    Original Message


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