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  • 1.  Shelf life, use life, expiry date

    Posted 04-Oct-2023 13:13

    Hi all,

    Hope you're well!

    I had a question about the topic of shelf life and expiry date.

    For a Class II, non-sterile device, if a company decides to omit shelf life testing, would that mean that they would not be able to put an expiry date on the device label?

    There is mechanical testing data to support the use life of 3 years for this product. (i.e., the product once opened can be used for 3 years).

    In that case, does use life have a specific symbol that can be added to the label? (Something like the 'Period after opening' symbol that the cosmetic industry uses.

    I am trying to find a guidance document on this but I haven't been able to find it yet.

    Thanks in advance!



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    Arundhati Kulkarni
    Ms
    York ON
    Canada
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  • 2.  RE: Shelf life, use life, expiry date

    Posted 04-Oct-2023 14:47

    To help get you started, much has been said here in the Forum previously on these general topics and distinctions between shelf life/expiry date and useful life in case you haven't yet had a chance to review the prior threads (e.g., see the 'Related Content') topics below.

    In general, any expiry date printed on the label must be supported by valid scientific evidence corroborating the stated expiry date for the subject device.  If no such evidence exists, then no expiry date would be allowed to be printed on the labels.



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


  • 3.  RE: Shelf life, use life, expiry date

    Posted 05-Oct-2023 06:30

    Hello Arundhati,

    There is a difference between shelf life and expiration date which has been described in numerous posts in this forum.  If you omit the shelf life, meaning it is not needed, then you probably do not need expiration date.  These can sometimes be the same thing.  An expiration date is when something in the product can deteriorate over time, e.g. a liquid or gel.  A shelf life is typically when a product is validated for packaging and sterility, e.g. catheter in a sterile pouch.  Typically a non-sterile device might not have a shelf life or have shelf life established because some component may degrade over time, e.g. a plastic or silicone.  It really depends on the product.

    There is no "useable life" symbol - there may be a "use by" condition for the product - though in the medical device field a use by would either be a shelf life or expiration date.  Useable life of a product could be defined - depending on the product type - and this would typically be described in the Instructions for Use (IFU) such as a product which is used over a long period of time, a product which is re-processed, or a product which may require servicing/repair.



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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 4.  RE: Shelf life, use life, expiry date

    Posted 05-Oct-2023 09:54

    Distinguish, as you did, between shelf life and use life.

    In shelf life something in the product changes over time and eventually goes out of specification. This happens while the product is on the shelf, unopened and unused. To do shelf life testing you need to identify what changes and its specification limits. The test determines the length of time  starting at manufacture to go out of specification.

    Use life is similar but different. It starts when the product is opened. Again, something deteriorates over time. Use life determines the length of time starting at opening to go out of specification.

    If nothing reasonably deteriorates on the shelf you don't need shelf life testing.

    I don't know of a symbol for use life, but you could develop one and describe it in the IFU.



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    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
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    Original Message


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