Regulatory Open Forum

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  • 1.  Export from OUS Manufacturing Site

    Posted 12-Feb-2015 10:18
    Does FDA regulate a US company when they ship/export a product from an OUS manufacturing site to another OUS location?  Are there any forms or applications required with US FDA for this?

    Thanks!

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    Julia Leslie
    Regulatory Specialist
    Houston TX
    United States
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  • 2.  RE: Export from OUS Manufacturing Site

    Posted 13-Feb-2015 06:42
    Hi Julia,

    If the product is being shipped exclusively outside the US, with no transit into or out of the US, then FDA has no jurisdiction over that product.  FDA does have jurisdiction, and various import/export regulations apply, if the product is imported into the US or exported from the US at any time.

    Hope this helps.

    Julie Broderick

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    Julie Broderick
    Principal/Consultant
    Winchester MA
    United States
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    Original Message


  • 3.  RE: Export from OUS Manufacturing Site

    Posted 13-Feb-2015 08:20
    Hi Julia.

    My initial thought on this is so long as the product never enters US commerce, the FDA would not be involved in any form.  The FDA only has jurisdiction over products that actively enter US commerce for sale within the US.  So, even if the product were to be produced ex-US, shipped to the US for warehousing and then shipped ex-US again, the FDA would likely not get involved.  However, if any of the product were to be shipped into the US for warehousing and then subsequently enter the US market, FDA would have full authority at this point.

    Remember though - even if the US FDA does not have jurisdiction over your product, the country where the product is manufactured might and invariably the country where you are planning to sell the product will have jurisdiction so you need to ensure you are compliant with the laws as applicable to the product.

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    Victor Mencarelli
    Sr. Manager - Regulatory Affairs
    United States
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    Original Message


  • 4.  RE: Export from OUS Manufacturing Site

    Posted 13-Feb-2015 08:33
    Morning Julia,

    It really depends. Will the product ever reach the market in the U.S./be used in the U.S.? There are also different types of registration requirements for different types of products regulated by FDA. This may be a place to start: http://www.fda.gov/ForIndustry/FDABasicsforIndustry/ucm234625.htm

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    Mark Paquin RAC
    Product Development, Clinical, and Regulatory Affairs Consultant
    Medical Products Market Consulting
    Miami Beach FL
    United States
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    Original Message