Unique Device Identifier (UDI)

Key facts

Legal basis

FD&C Act Section 519(f), added by FDAAA in 2007

Regulations

21 CFR Part 801, Subpart B and 21 CFR Part 830

Final rule

Published in 2013, phased in by device class

Issuing agencies

GS1, HIBCC and ICCBBA

Public database

GUDID, searchable through AccessGUDID from NLM

What is a Unique Device Identifier?

The UDI system gives each medical device version a standard identifier that people and machines can read. The code appears on device labels and packages, and for reusable devices that are reprocessed between uses, directly on the device itself.

Congress directed the Food and Drug Administration (FDA) to create the system in the Food and Drug Administration Amendments Act of 2007 (FDAAA), and FDA issued the final rule in 2013. Requirements phased in starting in 2014 with Class III devices and moved to lower-risk devices over the following years, with exceptions for some Class I devices.

Labelers obtain codes from FDA-accredited issuing agencies and submit the device identifier and key attributes to the Global Unique Device Identification Database (GUDID).

How a UDI is structured

A UDI has two parts and two forms:

GUDID stores device identifiers and attributes such as brand name, model, description, FDA product code, premarket submission number, sterility, MRI safety status and latex content. It does not store production identifiers. The PI in a UDI is unrelated to Prescribing Information (PI) for drugs.

• Device identifier (DI): the mandatory, fixed part that identifies the labeler and the specific version or model of the device.
• Production identifier (PI): the variable part, when included on the label, such as lot or batch number, serial number, expiration date or manufacturing date.
• Plain text form: characters people can read on the label.
• Automatic identification and data capture (AIDC) form: a barcode, 2D symbol or RFID tag that scanners can read.

Why the UDI matters

UDIs make device data joinable across the health system:

• Recalls and safety: UDIs help hospitals and FDA identify exactly which devices and lots are affected, and adverse event reports can include them.
• Supply chain: hospitals scan UDIs to track implants, manage expiring stock and reconcile purchasing data across distributors.
• Electronic health records: the ONC Health IT Certification Program includes an implantable device list criterion that records UDIs for patients.
• Market analysis: FDA product codes and premarket submission numbers in GUDID let analysts group devices by type, count models by manufacturer and join device data to 510(k) and PMA records.

Limitations of UDI data

UDIs are not required on standard health insurance claims, so claims data rarely shows which device model a patient received. GUDID attributes are submitted by labelers, so quality and completeness vary.