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  • 1.  Sample Retention Time

    This message was posted by a user wishing to remain anonymous
    Posted 26-Dec-2017 09:20
    This message was posted by a user wishing to remain anonymous

    Does anybody know what the sample retention time is for personal lubricant and personal care products or can somebody direct me to a source where I may find that information?

    Thank you.


  • 2.  RE: Sample Retention Time

    Posted 27-Dec-2017 12:39
    I assumed personal lubricants would be approved & regulated as drugs but was surprised to find they are regulated as class 1/2 devices!

    https://www.linkedin.com/pulse/how-fda-classifies-personal-lubricants-what-510k-andreas-maulhardt

    Based on the formulation and intended use, the requirements vary. I looked at a few 510k summaries, they cover basic testing like biocompatibility, shelf life, material compatibility etc. Could you elaborate on what you mean by sample retention?

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    Vidyalakshmi Jayaraman
    RA specialist
    MA
    United States
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  • 3.  RE: Sample Retention Time

    Posted 28-Dec-2017 00:25
    Hi,

    I request you to refer the following link

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=211.170 - this one if for USFDA

    https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/pdfs-en/2005_12_14_annex19_en.pdf - this one is for EU agency.


    Hope the  information is suffice for your intended purpose.

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    Tushar Premchandani PHD
    Assistant Manager RA
    Olive Healthcare
    Daman
    India
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  • 4.  RE: Sample Retention Time

    This message was posted by a user wishing to remain anonymous
    Posted 29-Dec-2017 13:07
    This message was posted by a user wishing to remain anonymous

    Our products are not pharmaceuticals so these wouldn't apply in this case.  Thank you for taking time to respond.


  • 5.  RE: Sample Retention Time

    Posted 28-Dec-2017 06:22
    Sample retention time should be based on the shelf life/expiration date of the finished devices.  You most likely will not find a definitive source, because this information needs to be established by the organisation themselves.  As such, if you have a personal lubricant with an expiration date (or shelf life) of say 5 years, you would want to have a sample retention time at least 5 years from the date of manufacture.  And it is always a good idea to extend the sample retention time beyond that for your established period of time, e.g. 6 months, 1 year, etc.  Because inevitably you will have those customers call up that said they used the product, it did not work, and then realised it was 6 months past the expiration date.

    You should establish a valid sampling method and sample size for the retention period.  As example, if your personal lubricants are packaged in containers of 50 mL with batch sizes of typically 1000 units, you have to establish the sampling method from the finished batch and then a quantity say 10 units for sample retention.  All of this should be defined, include rationale, and documented.  The shelf life, sample retention time, sample retention quantity is left up to each organisation to define themselves as there is any number of different medical devices.  it should be noted that there is no regulatory requirement in ISO 13485 or FDA QSR 21 CFR 820 for maintaining retained samples, but it is definitely good business practice, i.e. investigating customer complaints.

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    Richard Vincins RAC
    Vice President Regulatory Affairs
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  • 6.  RE: Sample Retention Time

    Posted 28-Dec-2017 11:53
    I agree with Richard.
    Lubricants (unless they have some drug claims) are considered to be medical devices within USFDA.
    There are no specific requirements for sample retention. You would have to decide it internally. Maybe the expected lifetime of the device will be just enough.

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    Artur Shchukin
    New York NY
    United States
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  • 7.  RE: Sample Retention Time

    This message was posted by a user wishing to remain anonymous
    Posted 29-Dec-2017 13:07
    This message was posted by a user wishing to remain anonymous

    Thank you for your feedback as well.


  • 8.  RE: Sample Retention Time

    This message was posted by a user wishing to remain anonymous
    Posted 29-Dec-2017 13:07
    This message was posted by a user wishing to remain anonymous

    Richard, Would you recommend following the same internal decision process for cosmetic products?


  • 9.  RE: Sample Retention Time

    This message was posted by a user wishing to remain anonymous
    Posted 29-Dec-2017 13:07
    This message was posted by a user wishing to remain anonymous

    Richard, Thank you for your detailed answer. Very very helpful information!.