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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.
In my case, we (A company) produce and provide key raw material, product design and labelling information to toll manufacturer (company B) to assemble/pack the finished device. Which company should be considered as "manufacturer"? Seems definition would apply to both.
Product is owned and sold by us A company, on the package, should we label "manufactured by A company" or "manufactured for A company?