Medical Devices

Unique Device Identification(UDI)

A system for identifying medical devices through their distribution and use using a unique numeric or alphanumeric code.

Usage Examples

UDI barcodes were implemented on all Class III devices.
The UDI enabled rapid identification of recalled devices.
GUDID registration is required before commercial distribution.

What is UDI?

The Unique Device Identification (UDI) system assigns a unique identifier to medical devices, enabling improved tracking through manufacturing, distribution, and clinical use. UDI supports better post-market surveillance, adverse event reporting, and recall management.

UDI consists of a Device Identifier (DI) identifying the labeler and specific device version, and a Production Identifier (PI) including lot/batch, serial number, expiration date, or manufacturing date as applicable.

UDI must appear on device labels and packages as both human-readable text and machine-readable format (barcode or RFID). Device information is submitted to FDA's Global UDI Database (GUDID).

Regulatory Context

This term appears most often in medical devices workflows where submission quality, regulatory evidence, and audit readiness depend on consistent language. It is commonly referenced alongside 21 CFR 830.

FDA CDRHEMAHealth Canada

When This Matters

UDI barcodes were implemented on all Class III devices.
The UDI enabled rapid identification of recalled devices.
GUDID registration is required before commercial distribution.

Common Mistakes

Using drug-only submission assumptions for device regulatory pathways.
Ignoring post-market obligations in pre-market planning.
Weak predicate and classification rationale in dossier narratives.

Related Regulations

21 CFR 830

Frequently Asked Questions

UDI requirements were phased in by device class. Most Class III devices required UDI by 2014, Class II by 2016-2018, and Class I by 2022. Certain devices have exemptions.

The Global Unique Device Identification Database (GUDID) is FDA's database containing device identification information. Labelers must submit device information to GUDID before commercial distribution.