Regulatory Open Forum

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  • 1.  Device labels and "immediate container"

    Posted 31-Oct-2017 15:33
    We are designing a class II medical device that will have multiple interconnected components and are working on label design. I'm a little unsure whether the FDA requirements for label content must be placed on the device components themselves (i.e., the enclosures) or if it should be placed on the package (box) that contains all components. I can't seem to find any guidance on how "immediate container" is interpreted by the FDA. Any insight would be greatly appreciated.

    Aimee Feuser
    Chicago IL
    United States

  • 2.  RE: Device labels and "immediate container"

    Posted 03-Nov-2017 12:52
    Interesting question, Aimee. 

    CFR Part 801 governs labeling of devices and states that any label information on inner containers must also be provided on outer containers unless the outer container is clear and the inner labels can be easily read. 

    The section that I see that addresses the labeling of inner containers is in Section 801.62 (e)(2) which states:
    In the case of a device that is marketed with both outer and inner retail containers bearing the mandatory label information required by this part and the inner container is not intended to be sold separately, the net quantity of contents placement requirement of this section applicable to such inner container is waived.

    That being said, labeling inner containers aids lot traceability which is an FDA requirement.  It also improves contents identification at point of use.  If the products are sterile the inner containers may have different expiration dates.  In that case the inner containers should be labeled and the outer container should bear the earliest date of the inner container expiration dates.

    Both regulatory requirements and your customer input guide your product design requirements and that includes labeling requirements.


    John Minier, RAC
    Consultant, Principal
    Minier Medical Device Consulting
    Highland Mills, NY
    United States