21 CFR Part 830 — Unique Device Identification

21 CFR Part 830 establishes the system for Unique Device Identification (UDI) of medical devices distributed in the United States. It requires that most medical devices bear a unique identifier on their label and packages, enabling more accurate reporting of adverse events, more efficient device recalls, and better tracking of devices throughout the supply chain.

Overview

Background

Part 830 was established by the FDA as mandated by the Food and Drug Administration Amendments Act of 2007 (FDAAA). The UDI system was designed to create a consistent, standardized identification system for medical devices, improving patient safety by facilitating more effective post-market surveillance and enabling rapid identification of devices in the field.

Applicability

This regulation applies to manufacturers (labelers) of medical devices that are marketed in the United States and required to be labeled with a UDI. The requirements apply to most devices, with implementation timelines that varied by device risk class. It covers UDI format, label placement, data submission to the Global Unique Device Identification Database (GUDID), and exceptions for certain device types.

Core Principles

Unique device identifier assignment

Device identifier and production identifier components

Label and package marking requirements

GUDID database submission

Issuing agency accreditation

Direct marking requirements for reusable devices

Compliance date schedules by risk class

Exception and alternative processes