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  • 1.  Label Reproduction in Instructions for Use

    Posted 10-Jul-2019 16:19

    Hi All,

    I have worked in the medical laser industry for the majority of my career, and I have always included reproductions of product labels in the user manual, because this is a requirement of IEC 60825-1 (Safety of Laser Products). Can anyone tell me if there is a similar requirement for non-laser devices? For example, does FDA require labels to be reproduced in the user manual?

    Please cite specific regulations or standards, if possible.

    Thanks,
    Julia



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    Julia Brown
    San Francisco, CA
    United States
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  • 2.  RE: Label Reproduction in Instructions for Use

    Posted 11-Jul-2019 03:33
    Julia,

    There is no requirement to reproduce the content of product labels specifically, however, much of the information will be included in the Instructions for Use contained in the product labelling.  As an example, the manufacturer information, product description, maybe some warnings, information on product such as sterility, electrical parts, etc.  What would not necessarily be included in the IFU would be product specific information on the label not appropriate in the IFU because this changes, i.e. lot number, expiration date.  But indeed you should make sure content in the product label is consistent with content in the IFU - I have seen on rare occasions where these are not matching (even the product name surprisingly).

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: Label Reproduction in Instructions for Use

    Posted 11-Jul-2019 12:21
    Thank you, Richard. Your answers on this forum are always so thorough and useful (and I sometimes wonder when you have time to earn a living =). I wasn't referring to the device-specific labels, complete with LOT, expiration date, etc., but rather a general representation of the product labels. Either way, you answered my question. We do include all of the information in the IFU, as well as a symbol key that explains the symbols on the labels.

    Thanks again for your reply!

    Julia

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    Julia Brown
    Manager, Regulatory Affairs
    Brisbane CA
    United States
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    Original Message


  • 4.  RE: Label Reproduction in Instructions for Use

    Posted 12-Jul-2019 01:56
    Maybe I do not sleep much - I read regulations to help with my insomnia haha just kidding.  I know the reference you were making in regard to IEC 60825-1 and as far currently I have never run across any other requirement for the representation of the label.  There may be some individual requirements in IEC/ISO particular standards, but have personally not seen this.  Though also in my experience, I see many electronic or electrical device manuals with the overview of the product, i.e. showing the on/off button, selector points, screens, indicators lights, etc.  Along with overview of the product, there is usually a view of the product label indicating where to find serial number and other safety information - similar to IEC 60825-1 requirements.  It is really good you are including the symbol key as this is helpful information and often required by regulatory agencies like FDA.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 5.  RE: Label Reproduction in Instructions for Use

    Posted 13-Jul-2019 02:03
    Hi Julia,

    In IEC 60601-1 and many particular (IEC 60601-2-XX / IEC/ISO 80601-2-XX) and some collateral (IEC 60601-1-XX) standards require symbols that are required for the device these symbols are replicated in the IFU.

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    Leonard (Leo) Eisner, P.E.
    The "IEC 60601 Guy"
    Principal Consultant, Eisner Safety Consultants
    Phone: (503) 244-6151
    Mobile: (503) 709-8328
    Email: Leo@EisnerSafety.com
    Website: www.EisnerSafety.com
    ------------------------------

    Original Message


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