GLOSSARYUS
Manufacturer (US)
Any person who designs, makes, assembles, or processes a finished device. Under Part 820 the term also covers contract sterilization, installation, and relabeling. The term extends to remanufacturers, repackers, specification developers, and initial distributors of foreign entities.
Avoid This Mistake
Installers, repackers, and remanufacturers count as manufacturers under Part 820. Specification developers and initial distributors of foreign entities that perform these functions count as well.