Regulatory Open Forum

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  • 1.  IVD Package Insert Revisions

    Posted 05-Jun-2014 09:48
    Does anyone know if you are required to submit minor IVD Package insert revisions to the FDA?  If so, can you tell me where the regulations are that indicate that?


    Joy Pelfrey
    Norman OK
    United States

  • 2.  RE: IVD Package Insert Revisions

    Posted 06-Jun-2014 09:14
    It depends.

    If the IVD was approved through a Pre-Market Application (PMA), then the updated labeling needs to be submitted either in a PMA supplement (for major labeling changes) or the annual report (for minor changes) - see 21CFR814.39 and 814.84.  

    If the IVD was cleared through a 510(k), then the updated labeling may lead to a new 510(k) (for major labeling changes - see FDA Guidance on when to submit a new 510(k)) or could be a Letter to File (for minor labeling changes). If the 510 (k) clearance letter had a special controls statement requiring a report to the FDA for all labeling changes, then a report should be submitted to the FDA.

    Raajdeep Venkatesan RAC
    US Regulatory Affairs and Quality Engineering Manager
    Arlington MA
    United States

  • 3.  RE: IVD Package Insert Revisions

    Posted 06-Jun-2014 11:58
    I think that as long as you follow the K97 Document (Significant Change guidance) and it indicates that the change is not significant and documentation only that you just need to inform them in your annual report. 


    Keri Froese RAC
    Quality Assurance Specialist
    Ottawa ON

  • 4.  RE: IVD Package Insert Revisions

    Posted 06-Jun-2014 13:25
    Hi Joy,
    Minor changes, such as typo correction, minor wording changes do not need to be submitted. Any change to performance needs to be carefully considered as a product change subject to review (what caused performance change?) Be aware that CLIA catagorization is based on the version that was cleared. In the event you need to apply for catagorization again for any reason, you should keep a list of all changes from that which was originally cleared.

    Sarah Parsons RAC
    Associate Director Regulatory Affairs
    Janssen Diagnostics
    Rochester NY
    United States