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Device Removals - FDA notification requirements

Discussion in 'US Medical Device Regulations' started by OrangeIsEnergy, Feb 19, 2016.

  1. OrangeIsEnergy

    OrangeIsEnergy Member

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    I am updating our Procedure on device removals, and in reading 21CFR7 Enforcement Policy and 21CFR806 Medical Devices; Reports of Corrections and Removals- I have a few questions...

    Is there a situation that you would be required to report a removal to the FDA under part 806, but NOT under part 7? Do you have to submit 2 reports or can you state in your report that it is addressing all elements of Part 806 & Part 7??

    It seems to me that the only part of Part 806 that isn't covered in Part 7 is that if you have a Stock Recovery or Market Withdrawal you have to keep the records for 2 years past the LOD (but no notification to FDA needed). Is that correct? I didn't see in Part 7 where it has retention time for the documentation of a recall...

    Lastly - would anyone want to share their procedure for Device Removals for a reference point for me? We make single use Class I IVD devices.
     
  2. MarkMeer

    MarkMeer Well-Known Member

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    I've (thankfully) never had to execute a recall, but I have gone through 2 FDA quality system audits, and my takeaway is that, if you are a medical device manufacturer, Part 806 is the regulation of interest to you with respect to recalls - no need to submit 2 reports.

    As far as a procedure, much of ours borrows from and/or references the FDA guidance documents "Guidance for Industry: Product Recalls, Including Removals and Corrections" and "Recalls, Corrections and Removals (Devices)". The inspectors didn't have any issues with it.

    Hope this helps somewhat... :)
    MM
     
  3. OrangeIsEnergy

    OrangeIsEnergy Member

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    Yeah, that helps. In writing our procedure, what I did is encompassed all requirements of Part 806 and Part 7 in the section outlining what is required in a report. Worst case scenario we would provide additional data in the event of a Recall. Hopefully we never have to, but it is there if we need it! Thanks!
     

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