Strategies for meeting FDA's UDI Rule

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
2

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
5

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
6

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
7

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)
of the final rule
Class II device– Labels and packages bear UDI
Class III permanently marked
Class II stand-alone software must provide its UDI
of the final rule
Class I device– Labels and packages bear UDI
Class II reprocessed permanently marked
Class I stand-alone software must provide its UDI
of the final rule
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

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

Strategies for meeting FDA's UDI Rule

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