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  • 1.  Use of FDA's eSubmitter for 806 correction and removal reporting

    Posted 16-Feb-2021 09:29

    Hello RAPS colleagues,

     

    I am seeking some input from the industry regarding their use of eSubmitter (i.e., electronic 806 for corrections and removals).  I would like to hear what are the benefits and challenges your company faces when submitting electronically.

     

    Please feel free to contact me directly at michelle_bandy@bd.com or through the RAPS Open Forum feed.

     

    Kind regards,

    Michelle

    Michelle Bandy, M.S., CQA, CQE, RAC
    Senior Manager, Post Market Quality

    Michelle.Bandy@bd.com
    7 Loveton Circle,
    Sparks, Maryland 21152-0999
    US, MC 703
    t: +1.410.316.4778
    c: +1.443.613.6747

    bd.com

     

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  • 2.  RE: Use of FDA's eSubmitter for 806 correction and removal reporting

    Posted 17-Feb-2021 09:44
    Michelle,

    I've used eSubmitter for years and it is a great tool. I cannot offer info on the 806 but I did find a link which I hope is helpful.

    https://www.fda.gov/files/Electronic-Submission-of-806-Reports-of-Corrections-and-Removals.pdf

    Although, initial or new filings in eSubmitter can be time consuming, and patience is key for good set-up, I think you will like it!

    Cynthia B.

    ------------------------------
    Cynthia Bristow
    Regulatory Affairs Associate
    Winston Salem NC
    United States
    ------------------------------

    Original Message


  • 3.  RE: Use of FDA's eSubmitter for 806 correction and removal reporting

    Posted 17-Feb-2021 11:24
    Hi Michelle,

    I do not recommend using eSubmitter to create your 806 Reports.  The recall coordinators are not accustomed to it, and I did several 806 reports last year, with the first three using the eSubmitter.  I spent several hours answering questions and explaining how to get the data from the report, and in some cases, the data was not presented in the way the recall coordinated needed.  For example, on one recall, there were two BRANDS, and in one BRAND, there were 7 Models, and a total of 10 lot numbers that were under recall.  The recall coordinator needed to know which lot numbers were aligned to which Models (obviously, at leas one Model had multiple lots) and the eSubmitter software does not account for that (or at least she and I couldn't figure it out).  She sent me a copy of a template and asked me to complete that template for all future recalls, and to provide an EXCEL Pivot Table showing quantities for International/Domestic distribution, by Consignee, by Model, by Lot.  

    I hope this helps.

    Sincerely,

    John Beasley, RAC (US)
    Founding Member and Senior Consultant
    MedTech Review, LLC
    www.medtechreview.com
    www.linkedin.com/in/medtechreview





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    Original Message


  • 4.  RE: Use of FDA's eSubmitter for 806 correction and removal reporting

    Posted 18-Feb-2021 09:34
    John Beasley, can you share that 806 template you mentioned the recall coordinator gave you?

    Thanks

    ------------------------------
    Al Van Houdt RAC
    Sr. Mgr. Regulatory Affairs & Compliance
    Snoqualmie WA
    United States
    ------------------------------

    Original Message


  • 5.  RE: Use of FDA's eSubmitter for 806 correction and removal reporting

    This message was posted by a user wishing to remain anonymous
    Posted 22-Feb-2021 09:05
    This message was posted by a user wishing to remain anonymous

    Currently FDA is encouraging industry to ​try eSubmitter for 806 reports. I think if you are familiar with eSubmitter and not familiar with recall reporting, it might help guide you to gather and provide an appropriate set of information, so they won't have to ask too many followup questions. If you're accustomed to generating appropriately formatted and readable 806 reports it might feel clunky in comparison.
    Original Message


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