Regulatory Open Forum

 View Only

  • 1.  Shelf life extension, combining tests

    This message was posted by a user wishing to remain anonymous
    Posted 22-Feb-2023 11:56
    This message was posted by a user wishing to remain anonymous

    We would like to extend the shelf life of our product to 6 years. 

    Today we have real-time aged data for 4 years and we are considering accelerating aging for the last 2 years.

    Are there any issues with having a mixture of real-time and accelerated aging to reach a total of 6 years? 



  • 2.  RE: Shelf life extension, combining tests

    Posted 22-Feb-2023 14:06

    FDA likes to have similar testing for shelf life over the life of the product but we have used equations to demonstrate equivalence to extend portions of shelf life without testing (Or accelerated with real life after) For example, if you release a device with 3 years shelf life due to battery expiration, you could demonstrate extended battery life using new software that conserves battery life and follow that up with real life aged devices eventually. If the device uses other specs than battery life that would need other types of testing in line with the initial FDA Clearance/Approval.



    ------------------------------
    Edward Panek
    VP, QA/RA
    Med Device
    USN Veteran
    Research into Neural Nets - https://www.twitch.tv/edosani
    ------------------------------

    Original Message


  • 3.  RE: Shelf life extension, combining tests

    Posted 22-Feb-2023 14:12

    As a general rule in the medical device sector, accelerated aging data is expected to be ultimately backed up with real-time data.  Consequently, you would still generally need to have real-time data to support the 6-year shelf life (such as by continuing your 4-year real-time study into a 6-year study) even though you can, in the interim, label with the 6-year expiration date based on the completed 6-year accelerated data.



    ------------------------------
    Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.
    ------------------------------

    Original Message


Related Content