US FDA Title 21 CFR Part 820 Pocket Guide
The requirements in this part govern the methods used in,
and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and
servicing of all finished devices intended for human use.
The requirements in this part are intended to ensure that
finished devices will be safe and effective and otherwise in
compliance with the Federal Food, Drug, and Cosmetic Act
This part establishes basic requirements applicable
to manufacturers of finished medical devices.