Regulatory Open Forum

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  • 1.  Importing medical device into US

    Posted 23-Aug-2023 14:39

    I'm hoping someone could provide some insight on this.  

    We are an academic institution where an investigator would like to do an investigator-initiated study with a medical device involving radiation that is unavailable in the US and would need to be imported.  The device company has agreed to provide the device but has never imported anything into the US before.  The question we are trying to figure out the answer to is who (the academic institution or the device company) should be signing FDA forms 2877 and 766.

    Lauren Wallace RAC
    Director of Clinical Research Regulatory Affairs
    Richmond VA
    United States

  • 2.  RE: Importing medical device into US

    Posted 24-Aug-2023 08:28
      |   view attached


    Quick overview (possibly this can steer you in the right direction): 

    Beth Casler
    Director of RA
    New London CT
    United States

  • 3.  RE: Importing medical device into US

    Posted 24-Aug-2023 09:27

    Hi Lauren,

    While I have not imported devices subject to radiation control before, it is typically the importer who is responsible for providing documentation stating how the device will be handled upon import. In this case, the academic institution would be the importer and would sign Form FDA 2877 and Form FDA 766. 

    This follows the logic of the process as well since the intention here is to control how the non-compliant device is used upon import and the manufacturer's declaration would hold little weight since they are not the one in control of the device once it is in the US.

    Ian Boland, RAC
    Regulatory Affairs Specialist
    United States