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  • 1.  Parallel PMA Supplements

    This message was posted by a user wishing to remain anonymous
    Posted 11-Nov-2022 08:08
    This message was posted by a user wishing to remain anonymous

    Does anyone have any experience with FDA of submitting parallel (not serial) 180-Day PMA supplements - one for a manufacturing site transfer and the other for a device design change?


  • 2.  RE: Parallel PMA Supplements

    This message was posted by a user wishing to remain anonymous
    Posted 15-Nov-2022 07:33
    This message was posted by a user wishing to remain anonymous

    This may depend on the OHT, but this was common in our field. I have done this multiple times and seen in the approval database that competitors also did so. As long as the risk of one doesn't have an effect on the other, you should be able to make a good argument that they can be reviewed independently and in parallel.
    Original Message


  • 3.  RE: Parallel PMA Supplements

    This message was posted by a user wishing to remain anonymous
    Posted 28-Jun-2023 09:03
    This message was posted by a user wishing to remain anonymous

    I am interested to know did you proceed with two separate supplements and why did you not combine them (I am assuming the design change was implemented at the new manufacturing site)?

    Kind regards.


    Original Message


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