Unique Device Identification (UDI) System

Regulatory Overview

January 27, 2016

Linda Sigg

Associate Director of Informatics

Office of Surveillance and Biometrics

Center for Devices and Radiological Health

U.S. Food and Drug Administration
Learning Objectives

• Recognize the four steps of the UDI System

• Understand the labeler requirements

• Know the UDI compliance dates

• Identify UDI adoption benefits

2 
Statutes and Regulation

FDA 

Amendments 

Act of 2007

(FDAAA) 

FDA Safety and 

Innovation Act 

of 2012

(FDASIA)

UDI Final 

Rule 

September 

24, 2013

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Objective of the UDI Program

• Facilitate the rapid and accurate 

identification of a device

• Enable access to important information 

concerning the device

• Provide a standard and clear way to 

document device use in electronic health 

records, clinical information systems, 

claims data sources and registries

“Establish a 

system to 

adequately 

identify devices 

through 

distribution and 

use” 

4 
Four Steps to a Successful 

UDI Program

Develop a standardized system to create the UDI

Place UDI on label and (sometimes) the device 

Create and maintain the Global UDI Database

Facilitate UDI Adoption and Implementation

5 
Four Steps to a Successful 

UDI Program

Develop a standardized system to create the UDI

Place UDI on label and (sometimes) the device 

Create and maintain the Global UDI Database

Facilitate UDI Adoption and Implementation

6 
Four Steps to a Successful 

UDI Program

Develop a standardized system to create the UDI

Place UDI on label and (sometimes) the device 

Create and maintain the Global UDI Database

Facilitate UDI Adoption and Implementation

7 
Four Steps to a Successful 

UDI Program

Develop a standardized system to create the UDI

Place UDI on label and (sometimes) the device 

Create and maintain the Global UDI Database

Facilitate UDI Adoption and Implementation

8 
What is a Label?

“Label" means a “display of written, printed, or graphic 

matter upon the immediate container of any article...” 

21 USC 321(k)

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What is a UDI?

Required on the device label, packages 

or, in some cases, on the device itself

Code in plain text and machine 

readable format (AIDC)

UDI = DI + PI 

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Device Identifier (DI)

Mandatory, fixed portion of UDI

• Identifies: 

• Labeler of device

• Specific version or model of device

• Never changes once assigned

Entered in Global UDI Database 

(GUDID)

• GUDID serves as the repository of key 

device identification information

• DI is the unique key

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Production Identifier (PI)

Conditional, variable portion of UDI

• Not required for Class I devices

May include (when on the device label):

• Lot, batch, serial number

• Expiration date, date of manufacture 

• HCT/P’s regulated as devices: the required 

distinct identification code

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Device Package

A device package contains a fixed quantity of a 

particular version or model of a device

Each level of the package requires a different UDI

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Package 

Levels

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Package Configuration of the Base Package
Package 

Levels

15

Package Configuration of the Base Package
Package 

Levels

16

Package Configuration of the Base Package
Package 

Levels

17

Package Configuration of the Base Package
Package 

Levels

18

Package Configuration of the Base Package
Shipping Containers are Not Device 

Packages and Do Not Require a UDI

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Direct Marking

• Intended to be used more than once, and

• Intended to be reprocessed before each use

In addition to its label, 

the device itself must 

also bear a permanent 

mark UDI if the device is:

• Easily readable plain text

• Automatic Identification and Data Capture (AIDC) technology 

or any alternative technology that will provide UDI on demand

UDI may be provided 

through either or both of 

the following:

• Identical to UDI that appears on the label of the device, or

• Different UDI used to distinguish the unpackaged device from 

any device package containing the device

The direct mark UDI may 

be:

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What is a Labeler?

Labeler is responsible for UDI 

requirements

Defined under 21 CFR 

801.3 as 

any person who causes a 

label to be:

Applied to a device with the 

intent that the device will be 

commercially distributed; or 

Replaced or modified with 

the intent that the device will 

be commercially distributed

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Examples of Labelers

Manufacturer (usually)

Contract Manufacturer

Private label distributor

Convenience Kit Assembler

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Quick Summary

UDI = 

DI + PI

Labels Packages Labelers

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Up Next How UDIs are created
Issuing Agencies

UDI regulations require:

• UDIs must be issued under a system operated by an 

FDA-accredited issuing agency

• Issuing Agency’s system must conform to the ISO 

standards incorporated into the UDI Rule

• Accreditation is granted for an initial term of 3 years

• May be renewed

• May be revoked by the FDA

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Issuing Agencies and Labelers

Labelers are required to:

• Work with at least one accredited Issuing Agency

• Use the Issuing Agency rules to build their UDI

Please see the FDA website for the list of 

currently accredited Issuing Agencies

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Dates on the device label 

must be in specified format

2014-01-30

Date Formats

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Summary of

Basic UDI Requirements

Device label and device 

packages must bear a UDI 

Key data for these devices 

must be submitted to GUDID

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Repository of key device identification information

Contains ONLY the DI; PIs are not submitted to nor stored in the GUDID

Contains only PI flags to indicate which PIs are on the device UDI

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Confidential – Please do not distribute

 

GUDID Search and Retrieval

• May 4, 2015: Launch of Beta AccessGUDID 

accessgudid.nlm.nih.gov

• Partnered with the National Library of Medicine (NLM) to 

provide:

– Public Search

– Database Download

– Web Services

• Releasable attributes of Published DI records are available

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Compliance Dates for UDI Requirements

Link: Details on Compliance Dates

Device

Label/GUDID/Date Format

Compliance Date

Class III (including Class III I/LS/LS1) 

Devices licensed under the PHS Act

September 24, 2014

Implantable, Life-Supporting and Life-Sustaining

(Class II, Class I & Unclassified) September 24, 2015

Class II (other than I/LS/LS1) September 24, 2016

Class I or Unclassified (other than I/LS/LS1) September 24, 2018

1 Implantable/Life-Supporting/Life-Sustaining

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Key General Exceptions

Class I cGMP exempted devices

Individual single-use devices sold and stored in a single package until removed for use

IDEs or devices used solely for nonclinical use

Devices intended solely for export from the US

Individual devices in convenience kits

Three year “grandfather”

General exceptions from UDI requirements include*

*See 21 CFR 801.30 for full list of exceptions 31
Exceptions and Alternatives

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General exceptions under 21 CFR 801.30

FDA may grant an individual exception or alternative

Submit exception and alternative requests to the UDI 

Helpdesk
UDI Benefits

 UDI assigned to 

devices

DI as key to unlock 

standard data

Clearly identify the device 

GUDID as authoritative source for 

key identification attributes

Link data sources to improve 

data capture, device evaluation 

and decision-making

Integrate UDI into 

electronic health 

information

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UDI Benefits

 

More accurate reporting of adverse events, 

better recall management, better 

comparative data

GUDID attributes as basis for clinical 

decision support – MRI, Latex, Sterile

More rapid and accurate device data 

capture and retrieval for patient care

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Key Benefits of UDI

Improve Patient Safety

More Accurate 

Understanding of Device 

Benefit-Risk Profile

Facilitate Device 

Innovation and Patient 

Access

Strengthening our National Medical Device Evaluation System

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Summary

 Remember the Four Steps of the UDI System

 Understand the UDI Labeler Requirements

 Label and Date Format

 GUDID Data Submission

 Know the UDI Compliance Dates

 Keep in mind the UDI Benefits

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FDA UDI Website: www.fda.gov/udi
Providing Industry Education

1. CDRH Learn – Multi-Media Industry Education

 over 80 modules - videos, audio recordings, power point presentations, software-based 

“how to” modules

 accessible on your portable devices: http://www.fda.gov/Training/CDRHLearn

2. Device Advice – Text-Based Education

 comprehensive regulatory information on premarket and postmarket topics:

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance

3. Division of Industry and Consumer Education (DICE) 

 If you have a question - Email: DICE@fda.hhs.gov 

 Phone: 1(800) 638-2041 or (301) 796-7100 (Live Agents 9am – 12:30 pm; 1-4:30 pm EST)

 Web Homepage: 

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ContactUs-- DivisionofIndustryandConsumerEducation/default.htm 

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