21 CFR 820 - Quality System Regulations

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 (the act).

This part establishes basic requirements applicable to manufacturers of finished medical devices.