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Hello Fellow Colleagues
My company is working on developing a gamma-sterilized version of our PEEK/titanium orthopedic device. Our engineering and marketing teams want the device labeled with a 5 year shelf life, but based on prior pharma experience I'm thinking that we may not be initially cleared for a 5 year shelf life based only on accelerated testing. If we do not have a previously validated packaging configuration that we can leverage for a 5 year (real time) shelf life, is there a limit on the shelf life that FDA will allow based solely on accelerated stability testing? I have not been able to find anything in the FDA device guidances that speaks to this.
Thank you for your insights!