Dear Anon,
The answer is which company name is on the final packaging. In addition, it is the company that is taking the legal responsibility for the device being the legal manufacturer (in the eyes of FDA). Both companies may do bits and pieces of the product realisation, but the legal manufacturer is that company who puts their name on their device and takes all of the legal responsibility for placing the product on the market - selling the finished product. Now when looking at registering your establishment that is a different aspect that must be considered who is the Specification Developer, Manufacturer, or Contract Manufacturer. If Company A is the legal manufacturer and Company B is the contract manufacturer (by your determination) then the labelling would say Manufactured For. If Company A is the legal manufacturer and Company B is considered a supplier (by your determination) then the labelling would say Manufactured By ... and the establishment registrations reflect as such.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 08-Feb-2019 15:00
From: Anonymous Member
Subject: define manufacturer
This message was posted by a user wishing to remain anonymous
Hi, Per FDA definition of "manufacturer":
(o) Manufacturer means any person who designs, manufactures, fabricates, assembles, or processes a finished device. Manufacturer includes but is not limited to those who perform the functions of contract sterilization, installation, relabeling, remanufacturing, repacking, or specification development, and initial distributors of foreign entities performing these functions.
My question is: we (A company) produce the key raw material, design the product and do the label/labelling, but we do use a toll manufacturer (B company) to assemble the finished device and pack the product. In this case, we or the toll manufacturer are considered "manufacturer" for final device? when we do labeling, should we "manufactured for A company" or "manufactured by A company"?
Thanks!