Now that FDA has indicated that they will be charging importers for Establishment Registration, some importers have asked me to clarify whether they need to register each and every facility that receives goods. For example, the importer may have a head office in Chicago and satellite distribution offices in Seattle, Oakland, Los Angeles, Dallas, Chicago, New York and Miami. If each satellite office had to register as a distinct Establishment, the importer would potentially have to pay the registration fee ($2575 starting October 1, 2012) SEVEN times. If the importer has even more offices throughout the United States, the registration costs could end up being quite onerous.
I contacted FDA’s Establishment Registration email address (they responded surprisingly quickly) and was initially told that yes, each facility would need to register for a separate Establishment number. I then asked how an importer should declare their Establishment for a shipment that was sent on a “direct-ship-to-customer model” where a shipment bypasses the importer’s distribution warehouses entirely. As the importing community is well aware, one of the best ways to reduce cost is to be able to directly ship goods from the manufacturer to the end customer, thereby reducing warehousing costs along the way. This question stumped the FDA Registration clerks. The question was elevated, and I received a very quick response from someone higher up in FDA. They clarified the following:
This information was of great relief to my importers of medical devices. I would like to applaud FDA and their quick response to my questions.
Feel free to contact me if you have any questions.