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  • 1.  drug-device combo, reusable vs. single use

    Posted 08-Apr-2014 21:40

    Hello everyone,
    Are there differences in CMC regulatory considerations when the drug-device combo is single use vs. reusable? This is when the pre-assembled medical device is the primary packaging.
    Jade



  • 2.  RE:drug-device combo, reusable vs. single use

    Posted 10-Apr-2014 08:25
    I would say no, except that for the multi use combination product you would have to show how you maintain sterility over mutliple uses and that it will maintain its functionality over the time frame it will be used (i.e number of uses etc)

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    Kathleen Sugrue-Richards
    Sr. Manager
    Amgen
    Douglas MA
    United States
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    Original Message


  • 3.  RE:drug-device combo, reusable vs. single use

    Posted 10-Apr-2014 12:10
    Jade,

    Since the product is reusable, your CMC program should incorporate appropriate aspects to the evaluation and performance of the combination including reliability, robustness and repeatability of the combination to perform under ICH, stability, through life, through use, mis-use, etc. You should also consider human factors testing to support the re-use of the combination. 

    You haven't indicated if the combination's primary mode of action is that of the drug or device so it is difficult to know who the primary review division will be but since it is packaged in the medical device and will be "re-used" then there are other CMC considerations that should be identified and incorporated into your CMC program.

    All the best,

    Dar

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    Darlene Rosario
    Principal Consultant RA, Quality and Compliance
    Velocity Consulting
    Ventura CA
    United States
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    Original Message


  • 4.  RE:drug-device combo, reusable vs. single use

    Posted 10-Apr-2014 12:54
    Hi Jade,

    You had mentioned that the combination is reusable. Is this reusable device (where drug is introduced into the device once empty and administered) or is it multiple-use combination (where the combination is administered in graduated manner until it is empty)?
    - If it is former case, your CMC should support such use and should also consider compatibility of device. Along with this, usability of device along with the suitability till the last refill.
    - If latter is the case, the CMC should demonstrate the stability of the drug till last administration and should address dispensability and contamination prevention. All the possible scenarios of use (including temperature fluctuation if it is a refrigerated drug) has to be factored in the study. If the drug is an injectable, maintenance of sterility becomes major concern.

    -------------------------------------------
    Shrivathsa Achar
    Manager
    Biocon Limited
    Bangalore
    India
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    Original Message