Initial importer

Initial importers register their establishment with FDA and have reporting duties as importers. Once they repackage or relabel, they are treated as manufacturers.

Initial importer means any importer who furthers the marketing of a device from a foreign manufacturer to the person who makes the final delivery or sale of the device to the ultimate consumer or user, but does not repackage, or otherwise change the container, wrapper, or labeling of the device or device package. (h) Any term defined in section 201 of the act shall have that meaning.

21 CFR, 807.3