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  • 1.  Medical devices (eye drops) stability testing

    Posted 13-Jan-2016 08:27

    Hi,

    I would appreciate guidance on standards and guidelines concerning the stability testing of Medical devices (eye drops).

    Is there any harmonized guidelines issued by any organization which covers the above.

    Thanks & Regards,

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    Meenakshi Verma
    Dubai
    United Arab Emirates
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  • 2.  RE: Medical devices (eye drops) stability testing

    Posted 18-Jan-2016 09:53

    I'm not sure why the eye drops are medical devices (many different reasons exist for this device regulatory path), but you might consider a reference to the OTC drug monograph for ophthalmic solutions (classified as drugs) for stability info which might inform you medical device decisions.

    http://www.fda.gov/downloads/drugs/developmentapprovalprocess/developmentresources/over-the-counterotcdrugs/statusofotcrulemakings/ucm347271.pdf

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    Joy Frestedt PHD, CPI, RAC, FRAPS
    President and CEO
    Frestedt Incorporated
    Saint Louis Park MN
    United States
    612-219-9982
    jf@frestedt.com

    Original Message


  • 3.  RE: Medical devices (eye drops) stability testing

    Posted 19-Jan-2016 00:24

    Hi Joy,

    Thank you for your reply. 

    The product is moisturizing eye drop containing hyaluronic acid which provide relief from symptoms associated with dry eyes.

    The product is a class IIa medical device in Europe. We have to register it in Gulf countries and the authority is asking for stability data at Zone IV.

    Are there any specific stability testing guidelines/standards for such products?

    Thanks & Regards,

    ------------------------------
    Meenakshi Verma
    Dubai
    United Arab Emirates

    Original Message


  • 4.  RE: Medical devices (eye drops) stability testing

    Posted 19-Jan-2016 13:01

    I agree with Joy, according to my understanding ophthalmic solutions can be classified as prescription and over the counter. It also exists

    Ophthalmic Drug-Device Combination Products, but to say "Medical devices (eye drops) stability testing" I have my doubts

    Here is a link.

    http://www.mddionline.com/article/toxicology-and-biocompatibility-testing-ophthalmic-drug-device-comb

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    Vilma Villalta
    Senior Scientist
    Ultra Fine, Inc.
    Doylestown PA
    United States

    Original Message