FDA plans to detain imports from foreign device manufacturers that do not identify a designated U.S. agent on the product's U.S. Customs invoice as a means to enforce the provision of the revised medical device reporting regulation. The agency says the import control mechanism will provide FDA leverage to ensure that foreign firms comply with the requirement to designate a U.S. agent.

Under the MDR reg, which becomes effective July 31, foreign manufacturers who distribute products in the U.S. must identify a domestic agent responsible for fulfilling FDA reporting requirements. Designated U.S. agents, defined as manufacturers under the reg, must register their facilities with FDA and assume responsibility for: filing all required MDR reports on behalf of the foreign manufacturer, conducting investigations of complaints or obtaining results of investigations conducted by the manufacturer, forwarding copies of any MDR reports and complaints to the manufacturer, establishing and maintaining complaint files, and submitting annual certification reports.

Implementation of the import detention policy will begin sometime after the effective date of the MDR reg, FDA says, and will be phased-in over a 6 to 12 month period after it is put into place.

During the phase-in period, a foreign company's initial shipment that does not list a U.S. designated agent will not be detained, but the firm will be contacted by FDA and notified of its obligation to designate a U.S. agent. Subsequent shipments from the same firm that do not identify an agent will not be allowed to proceed, the agency stresses. After the phase-in period expires, all shipments not bearing the name of a U.S. agent will be detained.

While the import control will not take effect immediately, all foreign manufacturers are required under the reg to forward the name of their U.S. designated agent to FDA by July 31. FDA plans to contact those U.S. firms listed as agents to verify their status.

Few of the estimated 5,000 foreign establishments (including subsidiaries and stand-alone firms) have identified an agent as of yet, according to FDA. While foreign subsidiaries presumably will list their U.S. operations as agents, stand-alone firms are turning to law firms and consultants, among others, to take on the responsibilities, the agency says. The U.S. designated agent requirement has generated controversy among manufacturers, some of which maintain that foreign firms are unable to find U.S. entities that are willing to assume the liability of serving as an agent.

DEVICE IMPORT DETENTION FOR NON-COMPLIANCE WITH MDR U.S. AGENT PROVISION PLANNED BY FDA; 5,000 FOREIGN ESTABLISHMENTS EXPECTED TO LIST AGENT WITH AGENCY

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