2. Outline
• What is UDI?
• Labelling Definitions (21 CFR 801.3)
• Status & Regulations – US FDA
• What is UDI composed of?
• UDI Requirements/Exceptions
• Compliance dates
• UDI Issuing Authority
• Global UDI Database (GUDID)
• Benefits
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3. Unique Device Identifier (UDI)
• A UDI is an alpha-numeric or numeric code, on a device label, its
packaging, or directly marked on the device itself.
• Represented in both plain text (i.e., human readable) and machine-
readable format (e.g., codes, linear or two-dimensional, or RFID
technology).
• Identifies a device through its distribution and use.
• Facilitate product recalls and assist in adverse event reporting.
• Created and maintained by the device manufacturer.
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4. Definitions (21 CFR 801.3)
• Universal Product Code (UPC): The product identifier used to identify an item sold at
retail in the United States.
• Version or model: All devices that have specifications, performance, size, and
composition, within limits set by the labeler.
• Shipping container: A container used during the shipment or transportation of
devices, and whose contents may vary from one shipment to another.
• Finished device: Any device or accessory to any device that is suitable for use or
capable of functioning.
• Lot or batch: One finished device or more that consist of a single type, model, class,
size, composition, or software version that are manufactured under essentially the
same conditions and that are intended to have uniform characteristics and quality
within specified limits.
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5. Definitions (21 CFR 801.3)
• Label: (21 USC 321(k))
A display of written, printed, or graphic matter upon the immediate container of any article; and a
requirement made by or under authority of this Act that any word, statement, or other information
appear on the label shall not be considered to be complied with unless such word, statement, or
other information also appears on the outside container or wrapper, if any there be, of the retail
package of such article, or is easily legible through the outside container or wrapper.
• Labeler:(21 CFR 801.3)
(1) Any person who causes a label to be applied to a device with the intent that the device will be
commercially distributed without any subsequent replacement or modification of the label; and
(2) Any person who causes the label of a device to be replaced or modified with the intent that the
device will be commercially distributed without any subsequent replacement or modification of the
label, except that the addition of the name of, and contact information for, a person who distributes
the device, without making any other changes to the label, is not a modification for the purposes of
determining whether a person is a labeler.
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6. Definitions (21 CFR 801.3)
• Automatic identification and data capture (AIDC): Any technology that conveys the
unique device identifier or the device identifier of a device in a form that can be
entered into an electronic patient record or other computer system via an automated
process.
• Expiration date: The date by which the label of a device states the device must or
should be used.
• Global Unique Device Identification Database (GUDID): The database that serves as
a repository of information to facilitate the identification of medical devices through
their distribution and use.
• UDI carrier: The means to convey the UDI and any non-UDI elements by using easily
readable plain-text and AIDC forms.
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7. Concept
• Framework for those regulatory authorities that intend to develop their UDI Systems that achieves a globally
harmonized approach to the UDI.
• Can be used at a local, national, or global level such that these systems are implemented without regional or
national differences.
• To provide a high-level conceptual view of how a global UDI System should work. It is recognized that further
additional guidance may be needed once these core concepts are accepted.
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GHTF
• Guidance on a
Unique Device
Identification (UDI)
System for Medical
Devices" by Global
Harmonization Task
Force (GHTF) on 16
September 2011
IMDRF
• UDI Guidance -
Unique Device
Identification (UDI)
of Medical Devices
on 9 December
2013
8. US FDA – Regulations
Food and Drug Administration
Amendments Act of 2007 (FDAAA)
Food and Drug Administration Safety
and Innovation Act of 2012 (FDASIA)
Federal Food, Drug, and Cosmetic Act
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The final rule (UDI
Rule) establishing
the unique device
identification system
was published on
September 24, 2013
• Labels of devices to bear unique identifier
• unique identifier shall adequately identify device through distribution and use, and
may include information on the lot number or serial number
9. UDI Implementation: Four Step Program
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Develop a Standardized system to create a UDI
Implement UDI labelling requirements
Create and maintain GUDID
Adoption and implementation by all stakeholders
10. US FDA Final Rule - Objective
• The UDI Rule is intended to create a standardized identification
system for medical devices
• To rapidly and definitively identify a device
• Key attributes that affect its safe and effective use.
• Uniform identification of most devices through distribution to the
point of use
• Reduce medical errors that result from misidentification of a device or
confusion concerning its appropriate use.
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11. UDI Implementation: Regulatory Requirements
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• Device label and device package must bear a UDI
21 CFR 801.20
• Device intended to be used more than once and intended to be
reprocessed before each use must be directly marked with a UDI
21 CFR 801.45
• Data for these devices must be submitted to Global Unique device
Identification Database(GUDID)
21 CFR 830.300
• Dates on the label must be in correct format
21 CFR 801.18
12. Unique device identifier (UDI) – 21 CFR 801.3 Definition
• An identifier that adequately identifies a device through its distribution and use by
meeting the requirements of CFR 830.20.
• A unique device identifier is composed of:
(1) A device identifier --a mandatory, fixed portion of a UDI that identifies the
specific version or model of a device and the labeler of that device; and
(2) A production identifier --a conditional, variable portion of a UDI that identifies
one or more of the following when included on the label of the device:
(i) The lot or batch within which a device was manufactured;
(ii) The serial number of a specific device;
(iii) The expiration date of a specific device;
(iv) The date a specific device was manufactured;
(v) For an HCT/P regulated as a device, the distinct identification code required by 1271.290(c) of this chapter.
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14. Fundamental concepts of a globally harmonized UDI System
• The UDI and UDI Carrier are based on standards
• A UDI applied to a medical device anywhere in the world should be able to be used
globally and to meet the UDI requirements of its regulatory authority
• National or local identification numbers should NOT be a substitute for UDI
• Regulatory authorities should not specify the procedure for modifying these UDI
standards
• The UDID core elements should not be modified
• The UDID should use the globally accepted
• XML/Electronic submission gateway - Health Level Seven International (HL7) Structured Product
Label (SPL)
• Web based interface for data submission(GUDID)
• Every medical device needs to be identified by a UDI, unless it is exempted
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15. What does the UDI final rule require?
• Generally, the label and package (i.e., lowest level of packaging) of every medical device,
unless otherwise excluded, must contain a unique number assigned by the manufacturer by
the compliance date established for the device.
• Some devices require direct marking.
• Labelers are required to update the information reported on the device via the FDA’s Global
Unique Device Identification Database (GUDID).
• The adoption of UDI by wholesale distributors is not required by the FDA regulation;
however, wholesale distributors that engage in relabeling (i.e., private labeling), reprocessing
and/or kitting of their medical devices at receipt will bear the responsibility of placing a UDI
on a device label, its packaging, or directly marked on the device itself.
• Does not provide any special requirements for a device that contains software as a
component of the device, but does require stand-alone medical software to be labeled with
a UDI.
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16. Devices which DO NOT require UDI
• Class I cGMP excepted devices
• Individual single-use devices 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 prior marketed devices
• FDA may grant exception or alternative
*Full list of exceptions found in 21 CFR 801.30
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17. Exemptions for medical devices under the final rule.
• Class I devices do not need to include production identifiers in the UDI; the UDI only
needs to contain a device identifier.
• All packaged single-use devices (i.e., all of a single version or model, intended to be
stored in that device package until removed for use, and which are not intended for
individual commercial distribution) are not required to have a UDI on the individual
device itself; however, the UDI is required to be printed on the multi-pack.
• Implantable medical devices are not required to be directly marked with a UDI;
however, the UDI is required to be on the lowest unit of use packaging.
• Class I devices labeled with a Universal Product Code (UPC) number may use the UPC
number as their UDI number on both their device label and package; Class I device
labeled with a UPC do not have to have an additional UDI on their device label and
package; however, a UDI/UPC is required on both the device label and the highest
level of packaging.
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18. All combination products much bear a UDI;
however, there are some exceptions
• If a combination product has a National Drug Code number, then it is exempt from
UDI requirement on the highest level of packaging.
• The NDC on the highest level of packaging will serve as the product’s UDI; however,
the device constituent parts must have their own UDI unless a combination product
is a single entity (i.e., combination products where the device constituent parts are
physically, chemically, or otherwise combined in way that you cannot separate those
or use the device separately from the combination product) a separate UDI is not
required on the device constituent parts and is only required on the highest level of
packaging.
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19. When will the UDI system be implemented?
• Initially focusing on high-risk medical devices and devices licensed under
the Public Health Service Act (e.g., implantable, life-supporting, and life
sustaining devices).
• September 24, 2014 - Class III medical device and/or a devices licensed under the Public Health
Service Act
• September 24, 2015 - Any implantable, life supporting, or life sustaining device not designated by
the FDA as Class III
• September 24, 2016 - Class II medical devices
• September 24, 2018 - Class I medical devices
• September 24, 2018 - Any other device not classified into Class I, II, or III
• September 24, 2020 – 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 bear a UDI as a permanent marking
on the device itself if the device is intended to be used more than once and intended to be
reprocessed before each use.
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20. What is a device package?
• For purposes of UDI label and GUDID submission requirements, a device package is a
package that contains a fixed quantity of a particular version or model of a device.
• Each different type of package, must have a unique identifier, 21 CFR 801.20(a)(2).
• More information: Section 3.1.2.1 of the Guidance titled “Global Unique Device
Identification Database (GUDID)” issued on June 27, 2014.
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22. Shipping containers are not device packages and do not require
a UDI
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Source: US FDA CDRH Learning slides
23. Direct Marking
• Devices must bear permanent marking providing the UDI on the device,
if
• Intended to be used more than once
• Intended to be reprocessed before each use
• UDI may be provided through either or both of the following
• Easily readable plain text
• AIDC technology or any alternative technology that will provide UDI on demand.
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25. Creation of UDIs: FDA -Accredited issuing agencies
• Operates a system for issuing UDI to labellers.
• System conforms to certain international consensus standards
ISO/IEC 15459-2, ISO/IEC 15459-4, ISO/IEC 15459-6
• Accreditation for initial term of 3 years and later renewed upon submission
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International Council for Commonality
in Blood Banking Automation.
Health Industry Business
Communications Council
Global Standards One
26. Global Unique Device Identification Database (GUDID)
• The GUDID is an FDA-administered database
• Repository of key device identification information
• Facilitate the identification of medical devices through their distribution
and use.
• Contains only DI; PIs are not submitted to GUDID
• Contain only PI flags to indicate which PIs are on the device
• 21 CFR §830.310 describes the information that must be reported to FDA
by the labeler.
• Each labeler must first request a GUDID account.
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27. GUDID Search and retrieval system
• https://accessgudid.nlm.nih.gov/
• FDA Partnered with National Library of medicine(NLM) to provide
• Public search
• Database download
• Web services
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