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  • 1.  Distributor symbol for US medical device label

    Posted 29-Mar-2021 14:09
    My company manufactures a medical device (not an IVD) in the US and have always distributed it through our own corporate sale force. We are planning to transfer all sales and distribution activities to a separate company. I have been asked what symbol to place adjacent to the distributor information on the new device labels. FDA recognized standard ISO 15223-1:2016 does not include a symbol for a distributor.

    Is it typical to place a symbol adjacent to the distributor name and place of business?
    If so, what symbol (e.g., Manufacturer) is used?
    If the distributor full name, address, and "distributed by" information is placed on the label, as shown below, won't that fulfill 21 CFR 801.1 requirements without use of a symbol?

    Distributed by Company XYZ
    Street, City, State, Zip USA

    Thank you,
    Mark

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    Mark Mortellaro
    Sr. Principal Regulatory Scientist
    Clarksburg MD
    United States
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  • 2.  RE: Distributor symbol for US medical device label

    Posted 30-Mar-2021 03:50

    Hello Mark,

    The distributor symbol is already included in the new version of ISO 15223-1, however it is now at the Approval stage and yet to be published.

    For your viewing purpose, you can click on this presentation from BSI and go to Page No. 10. This symbol is also available online in the ISO website. I hope you will find these information helpful.



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    Monoj Mon Kalita, PhD
    Senior RA Specialist
    New Taipei City
    Taiwan
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    Original Message


  • 3.  RE: Distributor symbol for US medical device label

    Posted 30-Mar-2021 04:44
    Hello Mark,

    There is no requirement for listing a distributor or having a symbol for a distributor in the United States.  On the labelling according to 21 CFR 801 you either indicate "Manufactured By" or "Manufactured For"  which in the case of Manufactured For often indicates the use of a Contract Manufacturer.  If a distributor uses the "Manufactured For [Distributor Name]" or "Distributed By [Distributor Name]" according to 21 CFR 801.1 be cautious as this is indicating they are taking on the regulatory responsibility for selling the product in the US.  There are intricate details involved but as long as you put your name as the Manufacturer on the label, there is no need to have any other special distributor designation.  There are circumstances where the distributors want different labelling showing only their name for customer retention purposes, so more important is having a distribution agreement in place clearly indicating roles and responsibilities for placing the product on the market in the US.  If private labelling is done in the US, again have to be clear on the medical device listing as the Manufacturer can get into some challenge if there is product (from a 510(k) clearance) which is not clearly indicating the manufacturer or listed properly.  And yes, at some point when ISO 15223 gets published the Distributor symbol can be used, but there are many other regulatory requirements which need to be considered then just a symbol on the label.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 4.  RE: Distributor symbol for US medical device label

    Posted 30-Mar-2021 08:06
    Hi Mark

    In the US, the sales/distributor's name is generally not required  to be on the label if yours is as manufacturer.

    Why would you do this? If you changed distributors, you would have to relabel....

    Unless you have to, all you might be doing is confusing the customer on who to contact and helping the distributor brand their business. Unless it is in your contract and  you are private labeling for them, and they are selling under their name, I would advise not unless required by regulation.   

    Just my thoughts.

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    Ginger Cantor, MBA, RAC
    Founder/Principal Consultant
    Centaur Consulting LLC
    River Falls, Wisconsin 54022 USA
    715-307-1850
    centaurconsultingllc@gmail.com
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    Original Message


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