Background

A recent policy change by the Food and Drug Administration requires companies designated as U.S. agents of foreign medical device manufacturers to accept that designation. This change will benefit customs brokers and others that may previously have been designated, and subject to the associated liability, without their knowledge.

Foreign manufacturers of FDA-regulated medical devices for sale in the U.S. must register with the FDA and designate a U.S. agent; i.e., a person or entity that is located within, or maintains an office in, the U.S. and acts as the domestic representative for the foreign manufacturer through which all communication with the FDA takes place. Some foreign manufacturers have named their U.S. customs brokers as their agents, but the brokers apparently were unaware of these designations because the agent information is submitted through an FDA system rather than the Automated Commercial Environment. Given that there is some liability associated with being a U.S. agent, the FDA has altered its system so that the foreign manufacturer can designate an agent but the agent must accept the designation.

The registration renewal period for foreign medical device manufacturers is now open through Dec. 31. Sandler, Travis & Rosenberg’s FDA Solutions Group offers registration, U.S. agent, and other related services. For more information, please contact Shelly Garg at (305) 894-1043.

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