Unique Device Identifier

(UDI)

Linda Chatwin, Esq. RAC Business Manager

Medical Regulatory Advisory

Services

AGENDA

Background of the rule

Regulations affected by the rule

Reason for the rule

Requirements for the unique device identifier

Requirements for the Global Unique Device

Identifier Database

Timelines and types of devices for compliance

Specifics about the rule

Question and Answer

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Background – Report Commissioned by FDA Issued March, 2006

In 2004, the United States Food and Drug Administration (U.S. FDA)

promulgated a regulation to require bar code identification on

pharmaceutical labeling

FDA asked for public comment on whether such a regulation should be

extended to medical devices

FDA chose not to include medical devices in the bar code rule, noting a

lack of standard and unique identifying system comparable to the

National Drug Code system

Product identification scenarios – 10 types with varying methods to

address problems.

Benefits of traceability examined

www.fda.gov/.../medicaldevices/deviceregulationandguidance/uniquedeviceidentification

3

Report Conclusion

POTENTIAL ROLE FOR GOVERNMENT

Thus, the Federal government might be able to generate net social

benefits by providing organizing principals for a UDI system. This is

a traditional role for government, i.e., organizing socially beneficial

efforts that the private sector will not organize itself. Further, as a

leading healthcare provider, the Federal government would capture

the supply chain savings from implementation of UDI.

Prepared by:

Eastern Research Group, Inc.

110 Hartwell Avenue

Lexington, MA 02421

4

Background - FDA

In response to growing calls for the development of a standardized

medical device identification system, Congress passed the Food

and Drug Administration Amendments Act of 2007 (FDAAA).

FDAAA mandated the U.S. Food and Drug Administration (FDA) to

create a unique device identification system that would enable

tracking and identification of medical devices across the medical

device lifecycle (i.e., from production through use in clinical

practice).

In response to this mandate, on July 10, 2012, the FDA published its

Proposed Rule for a Unique Device Identification System in the

Federal Register

http://www.fda.gov/medicaldevices/newsevents/workshopsconferences/ucm338201.htm

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FDA Pilot Activities

On November 30, 2010, FDA published the result of Pilot Activities

conducted over the previous 2 years

Focused UDI pilot activity gathered information on the business

processes for those stakeholders interested in regulation,

manufacture and use of medical devices

Identified issues and answered questions about populating and using

the UDI database to improve the identification of device information

and ultimately to improve their safe and effective use

Resolved many issues which lead to release of the proposed UDI rule

on July 3, 2012

Final rule issued September 24, 2013

http://www.fda.gov/medicaldevices/deviceregulationandguidance/uniquedeviceidentificati

on/ucm235962.htm

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Regulations Affected by UDI Rule

PART 801—LABELING

Subpart A—[Amended]

Subpart B—Labeling Requirements for Unique Device Identification

PART 803—MEDICAL DEVICE REPORTING

PART 806—MEDICAL DEVICES; REPORTS OF CORRECTIONS AND

REMOVALS

PART 810—MEDICAL DEVICE RECALL AUTHORITY

PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES

PART 820—QUALITY SYSTEM REGULATION

PART 821—MEDICAL DEVICE TRACKING REQUIREMENTS

PART 822—POSTMARKET SURVEILLANCE

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UDI Reasons for Rule

The Unique Device Identification (UDI) is a unique number

pertaining to a medical device that enables

- Traceability of devices more efficiently

- Enhances capture of correct information about devices

and reduce medical errors

- Enhances effective adverse event reporting

- Allow easier recall of devices

- Fights against counterfeiting

- Lead to a global device identification system

Unique Device Identifier System

• UDI = Device Identifier (DI) + Production Identifier (PI)

Source: FDA website

UDI - Device Identifier (DI)

mandatory, fixed portion of a UDI,

that identifies

- Labeler

- Specific version or Model of a Device

UDI – Production Identifier (PI)

a conditional, variable portion that identifies

- LOT or batch number

- Serial number

- Expiration date

- Date a specific device was manufactured

- Distinct identification code required by §1271.290(c) for a

human cell, tissue, or cellular and tissue-based product

(HCT/P) regulated as a device.

Unique Device Identifier System

Both formats:

Human readable (alphanumeric)

and

Automatic Identification and Data Capture (AIDC)

in compliance with globally accepted standards

- Series of ISO/IEC 15459-2, ISO/IEC 15459-4 and ISO 15459-6:

Information technology -- Unique identifiers

- ISO/IEC 16022 :2006 Information technology – Automatic identification and

data capture techniques – Data Matrix bar code symbology specification;

- ISO/IEC 18004:2006 IT AIDC techniques QR Code 2005 bar code

symbology specification;

- ISO/IEC 15417:2007 IT AIDC techniques – Code 128 bar code symbology

specification.

US FDA

Final Rule -Compliance Dates for the UDI

Compliance Date Requirement

1 year after publication of

the final rule (September

24, 2014)

Class III device– Labels and packages bear UDI

Data submitted to GUDID

Class III stand-alone software must provide its UDI

2 years after publication

of the final rule

(September 24, 2015)

The labels and packages of implantable, life-supporting, and

life-sustaining, used more than once, reprocessed, stand-

alone software devices must bear a UDI. (Permanent if

reused)

Data submitted to GUDID

3 years after publication

of the final rule

(September 24, 2016)

Class II device– Labels and packages bear UDI

Class III permanently marked

Data submitted to GUDID

Class II stand-alone software must provide its UDI

5 years after publication

of the final rule

(September 24, 2018)

Class I device– Labels and packages bear UDI

Class II reprocessed permanently marked

Data submitted to GUDID

Class I stand-alone software must provide its UDI

7 years after publication

of the final rule

(September 24, 2020)

All Device – (Class I devices, and devices that have not been

classified into class I, class II, or class III) that are required

to be labeled with a UDI, must a bear UDI

Source: https://www.federalregister.gov/articles/2013/09/24/2013-23059/unique-device-identification-system

US FDA - Final Rule

Source: http://www.fda.gov/medicaldevices/deviceregulationandguidance/uniquedeviceidentification/default.htm

- Class I Devices do not need to include Production Identifier

(PI)

- UDI Exemption: Individual Single-Use Devices, distributed in

the same device package and not intended for individual

distribution

- UDI Exemption:GMP-exempt class I devices as defined in 21

CFR Parts 862-892 (Code of Federal Regulations)

GUDID (Global Unique Device Identification Database)

Part of the UDI system, will include a standard set of basic identifying

elements

Most information will be made available to the public so that users of a

medical device can easily look up information about the device

The FDA has issued draft guidance is designed to help labelers

prepare to submit information to the GUDID

Describes key GUDID concepts such as accounts, user roles, the

device identifier record life cycle, package configurations, data

attributes

Guidance – Global UDI Database (GUDID)

- Global Unique Device Identification Database (GUDID)

(draft guidance, dated September 24, 2013)

- Appendix B: GUDID Data Elements Reference Table

(May 7, 2014)

- Appendix C: UDI Formats by FDA-Accredited Issuing Agency

(May 7, 2014)

- GUDID User Manual (Version 1, dated May 2014)

UDI will be built by one of the accredited standard organizations

according to ISO 15459 (GS1; HIBCC; ICCBBA).

Manufacturer chooses to work with one or more of these issuing

agencies.

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

DID/ucm20038750.htm#guidance

Exceptions General exceptions from the requirement for the label of a device to bear a unique

device identifier (§ 801.30)

The UDI rule provides exceptions from the requirements of § 801.20 for certain

categories of devices. A labeler of a device identified in § 801.30 is not required to

request an exception from FDA.

Request for an exception from or alternative to a UDI requirement (§ 801.55)

A labeler may submit a request for an exception from or alternative to the requirement for

the label of a device to bear a unique device identifier (§ 801.204) or other UDI

requirement under 21 CFR 801 Subpart B (Labeling Requirements for Unique Device

Identification) for a specified device or a specified type of device

Time extension for a class III medical device or a device licensed under the Public

Health Service Act

A labeler may submit a request for a 1-year extension of the compliance dates for a class

III medical device or a device licensed under the Public Health Service Act. Such a

request must be submitted no later than June 23, 2014.

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

eptionsAlternativesandTimeExtensions/default.htm?source=govdelivery&utm_medium=email&utm

_source=govdelivery

Europe

Recommendation issued April, 2013

Reason: Current regulation does not include specific provisions on

traceability, which is essential in patient safety by facilitating

vigilance, market surveillance and transparency.

Action: EU commission recommends member states to integrate

unique device identification (UDI) system which is compatible in

each member state.

Expectation: Avoid the risk of incompatible and divergent systems

frustrating the objectives of the internal market.

Source: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2013:099:0017:0024:EN:PDF

Europe - UDI

- Effective with the upcoming EU Medical Device Regulation

- Covering

medical devices,

active implantable medical devices and

in vitro diagnostic (IVD) devices

- Fed into the EUDAMED database

IMDRF UDI Guidance Dec. 2013

Source: IMDRF

Examples – UDI

GS1

Examples – UDI - HIBCC

Examples – UDI

ICCBBA

THANK YOU.

Questions?

Linda Chatwin, Esq, RAC

UL Medical Regulatory Advisory Services

T: 1-360-815-5556

E: linda.chatwin@ul.com or Medical.Inquiry@ul.com

W: ulmedicaladvisory.com or www.ul.com/medical