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How are establisment activities defined for medical device exports?
The establishment activities are defined as follows. CONTRACT MANUFACTURER Manufactures a finished device to another establishment's specifications and places the device into commercial distribution. (Please note that contract manufacturers are also required to list their devices). CONTRACT STERILIZER Provides a sterilization service for another establishment's devices and places the device into commercial distribution. (Please note that contract sterilizers are also required to list the devices sterilized at their establishment). FOREIGN EXPORTER Exports or offers for export to the United States, a device manufactured or processed by another individual, partnership, corporation or association in a foreign country, including devices originally manufactured in the U.S. A foreign exporter must have an establishment address outside the U.S. MANUFACTURER Makes by chemical, physical, biological, or other procedures, any article that meets the definition of 'device' in section 201(h) of the Federal Food, Drug, and Cosmetic (FD&C) Act. REMANUFACTURER Processes, conditions, renovates, repackages, restores, or does any other act to a finished device that significantly changes the finished device's performance, safety, specifications, or in any way changes the intended use. REPACKAGER AND/OR RELABELER Repackager: Packages finished devices from bulk or repackages devices made for the establishment by a manufacturer into different containers (excluding shipping containers). Relabeler: Changes the content of the labeling from that supplied from the original manufacturer for distribution under the establishment's own name. A relabeler does not include establishments that do not change the original labeling but merely add their own name. INITIAL DISTRIBUTOR/ IMPORTER Takes first title to devices imported into the United States. An initial distributor must have a U.S. address. SPECIFICATION DEVELOPER Develops specifications for a device that is distributed under the establishment's own name but performs no manufacturing. This includes establishments that, in addition to developing specifications, also arrange for the manufacturing of devices labeled with another establishment's name by a contract manufacturer. REPROCESSOR OF SINGLE-USE DEVICES Performs remanufacturing operations on a single-use device. U.S. MANUFACTURER OF EXPORT ONLY DEVICES Manufactures medical devices that are not sold in the U.S. and are offered solely for export to foreign countries.
U.S. Food and Drug Administration (FDA)
http://www.fda.gov
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