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  • 1.  Record Retention for A Recall

    Posted 11-Sep-2017 15:47
    Dear Team,

    Can you please advise if record retention for a closed recall is now 6 years?

    Your input is greatly appreciated!

    Thanks,
    Trish

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    Trisha Nguyen
    RA Specialist, II
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  • 2.  RE: Record Retention for A Recall

    Posted 13-Sep-2017 11:57

    ​Hi Trisha,

    I am not 100% on this one - I haven't worked on recalls for a long time, but I saw this:
    Maintain such product distribution records as necessary to facilitate location of products that are being recalled. Such records should be maintained for a period of time that exceeds the shelf life and expected use of the product and is at least the length of time specified in other applicable regulations concerning records retention.

    The manufacturer or importer must retain all records for a period of two years beyond the expected life of the device, even if the manufacturer or importer has ceased to manufacture or import the device. Records required to be maintained must be transferred to the new manufacturer or importer of the device and maintained for the required period of time.

    (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/RecallsCorrectionsAndRemovals/default.htm)

    I haven't seen any references which state 6 years, and I think this makes more sense than a set number of years.  However if anyone has another source which states a fixed time period, I would be interested to know!

    Hope this helps!

    Liz



    ------------------------------
    Elizabeth Goldstein RAC
    Regulatory Affairs Project Manager
    United States
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    Original Message


  • 3.  RE: Record Retention for A Recall

    Posted 13-Sep-2017 11:58
    Edited by John Minier 13-Sep-2017 12:02

    Hi, Trisha,

    For the US, 21 CFR 7.59 states, "Such records should be maintained for a period of time that exceeds the shelf life and expected use of the product and is at least the length of time specified in other applicable regulations concerning records retention."

    21 CFR 600.12 for biologics states, "The retention period shall be no less than five years after the records of manufacture have been completed or six months after the latest expiration date for the individual product, whichever represents a later date."

    21 CFR 806.20(c) for devices states "The manufacturer or importer shall retain records required under this section for a period of 2 years beyond the expected life of the device, even if the manufacturer or importer has ceased to manufacture or import the device."

    I have not seen any country's recall retention times that are longer than this.

    Canada says manufacturers should keep records as long as the devices involved are being sold and for importers and distributors should keep their records for the projected useful life or expected shelf-life of the device.

    Perhaps there is another country from where the 6 year time frame you mentioned comes.  I would be interested to hear if anyone has heard of a longer period.

    I hope this helps.

    Regards,



    ------------------------------
    John Minier, RAC
    Consultant, Principal
    Minier Medical Device Consulting
    john@johnminier.com
    1(914)850-4432
    Highland Mills, NY
    United States
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    Original Message


  • 4.  RE: Record Retention for A Recall

    Posted 13-Sep-2017 13:22
    Liz & John,

    While I was waiting to receive comments from the group, I found the same information that you commented.

    Thanks All for the information!
    Trish


    ------------------------------
    Trisha Nguyen
    RA Specialist, II
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    Original Message


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