A foreign establishment cannot register with the FDA for the fiscal year 2013 without disclosing the names, addresses, and phone numbers of “all known importers” of its device in the United States. The definition of an “importer” is so broad under this new policy that it even classifies the sales agents, brokers, retailers and end-users of an imported device as “importers.”
It is not clear if the FDA’s new policy is even ethical and practical. There could be ethical concerns with the FDA requiring a business to disclose confidential information such as customer lists. The drafters of the new policy failed to anticipate its application under different scenarios. For example, if an exporter lists a sales agent as an 'importer’, should it also declare the name of a customer obtained through that agent as ‘importer’ under the “all known importers” rule of the policy?
Further, the FDA’s current registration system is inefficient in dealing with common importers for multiple device listings under a registration. For example, under the current system, a foreign establishment with multiple device listings must painstakingly populate importer information for each listing separately. There is no tool to populate common importer information automatically.
The unreasonable demands of the new policy and its inherent problems have caused not only an uproar in the exporter community, but also policy implementation difficulties for the FDA. In these circumstances, the survival of this new policy in its current form is doubtful. Foreign establishments should expect a revised policy or a guidance from the FDA soon.