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  • 1.  Ad Promos Materials Regulatory Department Internal Filing Questions

    This message was posted by a user wishing to remain anonymous
    Posted 14-Feb-2024 09:19
    This message was posted by a user wishing to remain anonymous

    This is a practical question or an internal practice question on the printed ad promo materials.  Typically, when marketing prints any ad promo materials, they will also give regulatory a copy, we regulatory file them in the cabinet, and have been doing this for years and the cabinet is running out of space…also no one ever sees these archived printed ad promo materials anymore, new people just look at the electronic version before it gets printed.  I certainly see the value of keeping these printed ad promos' materials in the regulatory cabinets, however at the same time, think it is a waste of time and space, I wanted to reach out to colleagues here to ask if you are still archiving these materials in RA offices physically for the expired ones, and for the newly printed ones, or skipped doing it nowadays?  Thanks for any feedback you may have!



  • 2.  RE: Ad Promos Materials Regulatory Department Internal Filing Questions

    Posted 14-Feb-2024 10:09

    Hello

    I think it is important for the Regulatory Affairs team to be involved in crafting the promotional materials, not just be on the receiving end! I hope I did not misunderstand your post.

    Having said that, you might consider reviewing your record retention policy, or create one if you don't already have it.

    Marketing and promotional materials can be considered as evidence to assess if the product is misbranded (see FD&C Act Section 201(n)).

    Best regards



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    Naveen Agarwal, Ph.D.
    Problem Solver | Knowledge Sharer.
    Let's Talk Risk!
    @https://naveenagarwalphd.substack.com/
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  • 3.  RE: Ad Promos Materials Regulatory Department Internal Filing Questions

    Posted 14-Feb-2024 10:15

    For the medical device space, the general requirement is that the change control/approval file must contain an exact copy (e.g., identical format, identical content) of what was disseminated/used.  Thus, if the actual ad/promo material is disseminated in hard copy format, then the official copy in the change control/approval file needs to be an identical hard copy.  However, if the quality system has been validated to be compliant with applicable requirements regarding electronic records and signatures (along with, or instead of, requirements for digital copies of hard copies), then the official change file copy of the hard copy could be a digital copy.  Similarly, if the actual ad/promo material is not disseminated in hard copy format (i.e., it's only disseminated in electronic format), then the official copy in the change control/approval file also needs to be in electronic format; but again only as long as the quality system is compliant with applicable requirements regarding electronic records and signatures.



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    Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright by ComplianceAcuity, Inc. All rights reserved.
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  • 4.  RE: Ad Promos Materials Regulatory Department Internal Filing Questions

    Posted 15-Feb-2024 09:57

    Many companies no longer keep those file cabinets, but use an electronic record of some sort - provided you validate electronic records as part of your QS. 

    Many of them keep both the design materials that were approved by whoever the companies required approvers are (reg, legal etc) and also a scanned copy of any materials that were distributed in hardcopy.

    If you just prefer hardcopy to official electronic copies, I'd highly suggest a document retention policy that allows you to toss older hard copies. Note - work with legal on this as there are always needs to consider any impacts on legal situations.

    Ginger



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    Ginger Glaser RAC
    Chief Technology Officer
    MN
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  • 5.  RE: Ad Promos Materials Regulatory Department Internal Filing Questions

    This message was posted by a user wishing to remain anonymous
    Posted 16-Feb-2024 09:15
    This message was posted by a user wishing to remain anonymous

    Thanks all for the valuable discussions and advice!  Thank you, Ginger, for your advice - yes consulting legal is a good idea, Many thanks!