Establishment

Each establishment registers with FDA separately. The definition of manufacture is wide: repackaging, relabeling, initial importation and developing specifications for devices made by someone else all count.

Establishment means a place of business under one management at one general physical location at which a device is manufactured, assembled, or otherwise processed. (d) Manufacture, preparation, propagation, compounding, assembly, or processing of a device means the making by chemical, physical, biological, or other procedures of any article that meets the definition of device in section 201(h) of the act. These terms include the following activities: (1) Repackaging or otherwise changing the container, wrapper, or labeling of any device package in furtherance of the distribution of the device from the original place of manufacture to the person who makes final delivery or sale to the ultimate consumer; (2) Initial importation of devices manufactured in foreign establishments; or (3) Initiation of specifications for devices that are manufactured by a second party for subsequent commercial distribution by the person initiating specifications.

21 CFR, 807.3