Regulatory Open Forum

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  • 1.  IVD label

    Posted 21-Nov-2011 18:44
    We sell an IVD test kit and have US customers who have requested additional items due to loss of some small parts that are part of the kit. We want to sell them a small jar that is part of the kit in order to meet the customer need for "replacement parts".

    The current small container label has the product name, our company logo, part code, lot number and expiry date. Will that meet the US requirements? or does the labeling need to provide more information such as the intended use, quantity, storage temperature, IVD symbol, place of manufacture?

    Thank you for any help and clarification of US codes.

    Susan Pruett
    Regulatory Affairs Associate
    Hardy Diagnostics
    Santa Maria CA
    United States

  • 2.  RE:IVD label

    Posted 22-Nov-2011 08:28

    William White
    Senior Consultant
    Quality System Strategies LLC
    Elkhart IN
    United States
    Although this is not an area of personal expertise, I would assume that the right starting point will be 21CFR809, Labeling for In Vitro Diagnostic Products.  It would seem logical that there is a requirement to meet the requirements of that regulation.