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  • 1.  Nonsterile Medical Device shelf life/stability testing

    Posted 21-May-2015 16:29

    I wanted to gauge some feedback from you regarding Non-Sterile Class II Medical Device, a 510(k) product made of Polysulfone.  The device in question currently has 3 year expiration date; my client is intending to improve the performance specification of the device (for the same intended uses).  My question is that it is necessary for my client to re-establish the expiration date, i.e., conducting full shelf life/stability testing for the subject product, given that there is no physical design change of the product?


    Look forward to your comments and feedback.

    Thanks
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    Lin Wu RAC
    Waltham MA
    United States
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  • 2.  RE:Nonsterile Medical Device shelf life/stability testing

    Posted 22-May-2015 07:20

    I'm just curious how the performance is improved with no physical design change. Must be a composition change then in the polymer? If so, then at least some mechanical and/or other accelerated stability testing should be considered to verify that the shelf life is not affected. Any thing found in accelerated should trigger a full real time study.

    Is there the potential for polymer degradation like brittleness or light activated changes to occur? If this is non-sterile, the packaging integrity and validation is clearly not linked to sterility but protection. On what basis was the 3 year life set originally? That's the criteria on which your client should be basing their decision.
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    Ginger Cantor RAC
    Centaur Consulting LLC, Owner and Principal Consultant
    River Falls WI
    United States
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    Original Message


  • 3.  RE: Nonsterile Medical Device shelf life/stability testing

    Posted 22-May-2015 10:00
    Hi, Lin,

    It sounds like this will require a materials engineer to determine the significance of the change and how it will affect the use of the product.  Temperature and sterilization can change Polysulfone properties depending on its composition.  You will need to document the change and how the risk of using the product will change as a result.  You will also need either a new validation of shelf life or an engineering rationale to justify not re-validating.

    The other thing to remember is that as a regulatory professional you will need to determine whether the change is significant enough to require a new 510(k).  If you determine that is it does not you can write a letter to file justifying your decision and reference the documentation mentioned above.  Then the next time you make a change that requires a new 510(k) you can include the new material at that time.   

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    John Minier RAC
    Small Bone Innovations, Inc
    Highland Mills NY
    United States
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    Original Message