| Registration & Listing |
Foreign EstablishmentsForeign establishments that manufacturer, prepare, propagate, compound, or process a device that is imported into the United States must register and list before importing those devices into the U.S. They must also review their registration and listing information on an annual basis between October 1 and December 31. All registration and listing information for foreign establishments must be submitted electronically using the FURLS system. Each foreign establishment must also designate a United States agent (U.S. agent). Updated October 25, 2007 |
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Center for Devices and Radiological Health / CDRH
