​What is a US Initial Importer?

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Under FDA regulations, 21 CFR § 807.3(g), an Initial Importer is defined as "any importer who furthers the marketing of a device from a foreign manufacturer to the person who makes the final delivery or sale of the device to the ultimate consumer or user, but does not repackage, or otherwise change the container, wrapper, or labeling of the device or device package." 

Under § 807.40(a), Initial Importers must register with the FDA and pay the annual registration fee ($9,280.00 in 2025). The Initial Importer must have a physical address in the United States staffed by individuals responsible for ensuring the compliance of imported devices with all applicable FDA laws and regulations. More information on who must register their establishment, list their devices, and pay the user fees can be found here.

Device Initial Importers have responsibilities under 21 CFR § 803 Medical Device Reporting, § 806 Reports of Corrections and Removals, and, in some cases, § 821 Medical Device Tracking. 

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Why is a US Initial Importer Required?

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Without an FDA-registered US Initial Importer, the FDA will not authorize the release of your goods for distribution in the United States and may issue a Notice of Action against your company.

 
The submission of incorrect information related to the device Initial Importer is a common entry error occurring during the medical device import process. Refer to the FDA website to see common entry errors. According the the FDA, "Submitting the incorrect device initial importer could result in either the distribution of products into U.S. commerce that may not meet the FDA's laws and regulations or the shipment being unnecessarily held for additional review." Many times, foreign establishments identify an importer of record, but not an FDA-registered Initial Importer, resulting in delays and/or noncompliance.