Companies that manufacture medical devices abroad (considered “foreign exporters” by the FDA) face a number of regulatory hurdles if they want to market their products in the U.S. These regulatory obligations include those imposed by U.S. Customs and Border Protection (CBP), as well as those imposed by the FDA.

CBP works collaboratively with the FDA to ensure that products entering the U.S. from abroad meet all regulatory demands. In its letter to industry about the import entry review process, the FDA states:

“When an imported product arrives in the U.S., certain information must be provided/transmitted electronically to the United States Customs and Border Protection (CBP). If the product is or may be regulated by USFDA [the United States Food and Drug Administration], CBP sends the import entry information to USFDA for verification to ensure that the product meets USFDA requirements. Without the proper information, USFDA may initiate a manual review of each line of your entry, which may lead to delays in its release to the importer/consignee.”

Among the information the FDA requires is the listing of a device initial importer. Under FDA regulations, an initial importer is “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.”

The FDA website further clarifies that an initial distributor (a term that is undefined in the regulations, but appears to be used synonymously with “initial importer”) is the entity that “takes first title to devices imported into the U.S.” An initial distributor must have a U.S. address.

Issues arise if a foreign exporter plans to distribute its product to multiple U.S. distributors but does not initially know which of various distributors will ultimately receive the products. This might occur when a foreign exporter ships its products to a U.S. warehouse and retains title to the products, and only later do any U.S. distributors take title to the products.

Although in the above-described scenario it would be impossible to designate an initial distributor when the products first cross into the U.S., the FDA nonetheless requires that some entity must be designated initial importer, or products may be held up at the border.

Given the FDA’s interpretation that any entity registered as a distributor can be considered an initial importer, some solutions to the above problem include:

  • Having an import/logistics company, or even a commercial carrier, serve as initial importer
  • Having a third party logistics warehouse, to which the products are shipped, serve as initial importer
  • Incorporating a U.S. branch of the foreign exporter to register and serve as its own initial importer