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  • 1.  Foreign Establishment initial registration

    This message was posted by a user wishing to remain anonymous
    Posted 02-Nov-2020 08:56
    This message was posted by a user wishing to remain anonymous

    Hi Guys, I need to confirm urgently if a foreign establishment/facility without a registered 510k can be registered or we need to wait after the submission of 510k.

    Thanks, it's urgent. Your help appreciated.


  • 2.  RE: Foreign Establishment initial registration

    Posted 03-Nov-2020 04:14
    Hello,

    I have not been on the "back end" of the FURLS database for a few months, but as far as I know a facility can be registered as an establishment any time.  The annual fee needs to be paid.  Also note once registered the facility can be subject to an inspection at any time.  To be honest, if the company is not yet selling a product in the United States either a Class I device or 510(k) product, there is not really any reason to register since the fee is quite a lot now.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: Foreign Establishment initial registration

    Posted 03-Nov-2020 09:17
    Like Richard said, you can complete your initial registration whenever - but it must be done before you begin distribution of medical devices in the US. For a product that requires 510(k), you need to have clearance before you can complete the device listing.

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    Jeffrey Freedman
    QA/RA Specialist III
    Lowell MA
    United States
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    Original Message


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