Regulatory Open Forum

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  • 1.  U.S Agent

    Posted 18-Feb-2022 17:35
    Dear all,

    Could a person as product US representative be an US agent?
    If no, does the foreign company have to set up a company in US before designing US  agent.

    Thank you in advance your help.


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    Nadine Adia
    Quebec QC
    Canada
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  • 2.  RE: U.S Agent

    Posted 19-Feb-2022 09:30
    The US agent can be an individual or a company. Basically it's someone who agrees to facilitate communication between FDA and the foreign company if needed. There are many companies offering that service.
    https://www.fda.gov/medical-devices/device-registration-and-listing/us-agents

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    Anne LeBlanc
    United States
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    Original Message


  • 3.  RE: U.S Agent

    Posted 20-Feb-2022 07:50
    Hi Nadine,
    Company does not necessarily require to set up a establishment , company needs to assigned an individual as their us agent who would perform all the communication and on behalf of your company. The agreement should be signed and same needs to be communicated to agency in the FDA

    https://www.fda.gov/medical-devices/device-registration-and-listing/us-agents

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    Pallavi Sharma
    Florham Park NJ
    United States
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    Original Message


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