Regulatory Open Forum

 View Only

  • 1.  Cellular Therapy Processing Product Classification

    This message was posted by a user wishing to remain anonymous
    Posted 01-Apr-2019 15:53
    This message was posted by a user wishing to remain anonymous

    I have a product used in processing vials freezing, unfreezing, agitating, etc) cells used in cellular therapy/regenerative medicine/stem cells (no specific  cell type) in a clinic or hospital (not necessarily from the same patient).  How are these products regulated?  I see big companies sell these type products under cellular therapy systems but don't see Biologic 510(k)s or regular 510(k)s for them.  How are they classified?  Are they even medical devices?  


  • 2.  RE: Cellular Therapy Processing Product Classification

    Posted 03-Apr-2019 10:20
    Hello,

    I think the answer at the moment is "need more information". The type of contact the product has with the cells, what it's use in processing is, what is the output of the product, etc. This type of information should be considered in determining if it's under 812, 809 or 880.

    Hope this helps!

    ------------------------------
    Ashley Clark RAC
    Gainesville FL
    United States
    ------------------------------

    Original Message


  • 3.  RE: Cellular Therapy Processing Product Classification

    Posted 04-Apr-2019 08:54
    I agree with Ashley, we need more information. Is this a cell bank? Are they used only in research or are they actually being administered to a patient?


    ------------------------------
    Joscelyn Bowersock MSc
    Quality and Regulatory Manager
    Huntersville NC
    United States
    jbowersock@carolinabiooncology.org
    ------------------------------

    Original Message


  • 4.  RE: Cellular Therapy Processing Product Classification

    This message was posted by a user wishing to remain anonymous
    Posted 08-Apr-2019 10:49
    This message was posted by a user wishing to remain anonymous

    There is no contact of this product to the cells (just a vial of cells inside of the freeze/thaw device).  The device would hold the vial. 

    The product would have a general indication for any type of cell that the hospital or clinic uses it for (no specific type of cell, no specific use).  This is not research use.  This is not a cell bank.  This would be a product sold to a hospital.  The physician would decide to administer the cells to the patient (thawing) or save the cells from a patient (freezing).  The physician would do this for whatever reason the physician decides (again no specific indication).  Cell categories could include stem cells, etc.  Thoughts?  I appreciate it.
    Original Message


Related Content