21 CFR 11, 820 QSR and 830 UDI

US FDA Title 21 CFR Parts 11 Electronic Records, 820 QSR and 830 Unique Device Identification 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 UDI regulation is designed to help companies understand, identify and trace medical devices through their distribution and use. When fully implemented, the label of most devices will include a unique device identifier (UDI) in human- and machine-readable form.

These two 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.