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  • 1.  Stability data for 510(k) for personal lubricant

    Posted 18-Jun-2015 08:27
    How much stability data is required at filing for a 510(k) for a personal lubricant?  I have seen companies file with 6 months accelerated following ICH guidelines or with 3 months following Consumer Health Products Association (CHPA) guidelines in order to get a 24 month shelf life.  Thank you.

    Regards,

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    David Lucking FL
    United States
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  • 2.  RE: Stability data for 510(k) for personal lubricant

    Posted 19-Jun-2015 09:57
    David,

    We are just completing a round of 510(k) questions on a personal lubricant.  You can definitely submit accelerated testing (while retaining samples for real time testing).  The accelerated testing length should support, of course, what you want to label your product regarding expiration dating.  However, I strongly encourage you to follow the USP series of standards to design your testing.  These standards for non sterile formulations would include 51, 61, 62, and 1111.  Hope this helps.

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    Barry Sands
    RQMIS Inc.
    Newburyport MA
    United States
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    Original Message


  • 3.  RE: Stability data for 510(k) for personal lubricant

    Posted 19-Jun-2015 10:32
    It may be helpful if you refer to a supplement to the USP.

    PMM 2014 at http://wp.me/P4xpOK-1bZ

    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    President and CEO | REGULATORY DOCTOR
    Phone (Toll-Free): 1-(800) 321-8567


    Original Message