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  • 1.  shelf life validation for 510k at FDA

    This message was posted by a user wishing to remain anonymous
    Posted 07-Jan-2022 08:50
    This message was posted by a user wishing to remain anonymous

    Dear FDA experts,
    I have a question regarding shelf life testing.

    In my former 510k with one device (powered muscle stimulation) we have to catch up accelerating testing for shelf life of electrodes because we didnt state the shelf life of electrodes at IFU.

    We have a similar device to approach now. Of cource the shelf life of electrodes is on focus. In 510k summary of similar devices, some dont have shelf life testing.

    This is my thought. Could you share your valuable opinion?
    • compare with predicate device which has the similar electrodes
    • provide calculation of 1 year shelf life in theory
    • or provide real time testing by bringing back some devices after 1 year on field to test basic performance

    I appreciate it for your contribution...

    Have a wonderful new year!

  • 2.  RE: shelf life validation for 510k at FDA

    Posted 07-Jan-2022 14:21
    My experience is that, if shelf life testing is required at all, FDA will generally require a certain limited amount of completed accelerated shelf life data in order to grant 510(k) clearance; let's say, enough to equate to a shelf life of 6-12 months.  That amount will be determined by prior precedent, device-specific guidance, and current prevailing preference by the applicable FDA reviewing panel/division.  This generally comes with a caveat that you supplement the accelerated data with real time studies being run in parallel.

    Sterile vs. non-sterile is a key factor (yet not necessarily the only factor) determining a requirement for labelled shelf life vs. no labeled shelf life.

    Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.

  • 3.  RE: shelf life validation for 510k at FDA

    Posted 09-Jan-2022 11:34
    Hello Anon,

    Happy new year !  There is some confusion in your question and sorry it is not quite so clear.  When submitting a 510(k) submission to FDA, shelf life testing is needed depending on type of device and generally as Kevin mentioned sterile versus non-sterile is a limiting factor, but not the only one as he mentions.  Shelf-life is also usually stated on the device labelling and sometimes the IFU, but the device packaging is more appropriate place because this would be where users access the device.  When submitting a 510(k) accelerated age testing is often accepted with commitment (understand a real-time stability/shelf life testing protocol is submitted) and then real-time aging/shelf-life is performed out to the specified time period internally to the company.  Just because there is nothing in a potential predicate device 510(k) Summary does not mean this would not be required.  There is no standard format or structure for 510(k) Summary and many versions are generated by different medical device manufacturers.  As there is no specific standard for shelf-life, expiration dating, stability dating of medical devices, might be recommended to consult a subject matter expert as these can be quite involved to determine proper accelerated and real-time testing protocols.  I have seen too many deficiencies in 510(k) submission related to shelf-life testing and can be a significant time factor in gaining clearance.

    Richard Vincins RAC
    Vice President Global Regulatory Affairs

  • 4.  RE: shelf life validation for 510k at FDA

    Posted 10-Jan-2022 08:28
    #1 have testing be directly related to intended use and safety of device
    #2 The easier it can be explained to an auditor, the better. Don't add complications.
    #3 Accelerated is ok if you plan to address real time - understand the Arrhenius Equations
    #4 Consistent testing protocols. Don't change methods
    #5 Identify and create complaint codes that might imply shelf life failure. 
    #6 Risk analysis of your test methodology. What assumptions are being made? (e.g. stored in certain temp and RH conditions, not dropped, not exposed to liquid, etc)

    ​We changed the duty cycle of our battery after release. This allowed the device to conserve energy. FDA accepted this logic given we provided the new duty cycle calculation to explain why the new design can be compared to the original design. In fact, after the initial release, it's very likely things will change. That's ok as long as the original design can be directly correlated to the new design mathematically.​​​​​​

    Edward Panek
    VP, QA/RA
    Med Device
    USN Veteran
    Research into Neural Nets -

  • 5.  RE: shelf life validation for 510k at FDA

    This message was posted by a user wishing to remain anonymous
    Posted 10-Jan-2022 12:29
    This message was posted by a user wishing to remain anonymous

    Thanks all and happy new year.

    Actually I get it that it is strict required for steril product. In this case it is an active unsteric product. The device specific guidance dosent mention shelf life.

    So it is good to know without mentioning of shelf lefe testing in 510k summary dosent mean no testing needed.

    We have the opinion that FDA want to see our consideration than testing. To potentially save the testing, we want to try the real time shelf life testing plus evaluation of critical components... I know it is risky