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  • 1.  PMA ownership transfer

    This message was posted by a user wishing to remain anonymous
    Posted 30-Jul-2019 11:55
    This message was posted by a user wishing to remain anonymous

    ​​Hi,
    I am looking for information about the possibility to benefit from a  transition period for the labeling updates implementation (name, address and logo of new owner on boxes and IFU), after the PMA transfer has been notified to the FDA. In other words, is it still possible to release product on the US market with the previous holder packaging items for limited period of time. If yes, is there a standard maximum duration, and what are the associated pre-requisites or conditions if any ?
    Thanks in advance !