Step-by-Step Approach of Unique Device Identification (UDI)
Step-by-Step Approach of
Unique Device Identification
June 3, 2014
History of UDI?
• 2007 – US Congress passed legislation directing
FDA to develop UDI System
• 2013 – International Device Regulators Forum
(IMDRF) established working group
• 2013 – FDA published UDI Final Rule and draft
Objective of UDI
• Global consistent system to improve visibility to UDI for patient
safety through higher quality information used in post-market
surveillance and in medical device reporting
• Fast identification of product issues and improved targeted field
• Improved supply chain efficiencies (manufacturing, logistic)
• Reduce counterfeiting
Not just a Label Change
• Product Master Database per facility
• Labeling and Packaging
• Submission of UDI data to a FDA GUDID
• Direct Part Marketing
What is UDI?
A unique numeric identifier composed of the
device identifier and production identifier(s)
that uniquely identifies a medical device
through distribution and use.
What are the Benefits of UDI?
• Reduce medical errors
• Simplify the integration of device use information into data systems.
• Provide for more rapid identification of medical devices with adverse
• Provide for more rapid identification of solutions to reported problems.
• Provide more accurate, more efficient resolution of device recalls.
• Better focused and more effective FDA safety communication.
• Other benefits:
- Can be used in educational and informational materials.
- Can be used in inventory management.
- Can be used in the provision of high quality medical services.
- Can help identify alternative devices.
What makes up a UDI?
• Device Identification (DI)
• Product Identification (PI)
Device Identification (DI)
• DI is a static unique number assigned to all product model numbers at
each packaging level.
• The number must use an accepted standard format.
• The accepted standard DI formats are currently provided by 3 companies.
- GS1 – Used by the majority of industry
- HIBCC – Health Industry Business Communications Council
- ICCBBA - International Council for Commonality in Blood Banking
Product Identification (PI)
• PI is a dynamic number that identifies how the product is
• It can include one or all of the following:
- Serial Number
- Lot Number
- Expiration Date
- Manufacturing Date
• UDI must be in plain human readable text and AIDC
(Automatic Identification and Data Capture)
• UDI applies to all levels of packaging down to the lowest
level (patient use/unit of use)
• UDI is not required on shipping containers (eg: brown
• The date format will be standardized:
YYYY-MM-DD (eg: 2013-09-20 for September 20, 2013)
YYMMDD for the GS1 bar code
Labeling for a Convenience Kit
• The final rule does not require devices within a
convenience kit to bear a UDI but does require the label
and each device package of every kit to bear a UDI.
Global Unique Device Identification
• Operated by the FDA to collect information on Medical Devices
• FDA has public facing website to share data with anyone (https://
• Some information submitted to the GUDID will be private (for FDA only)
What are the Challenges?
• Each Business must identify products
• Assign (Global Trade Item Number) GTINs where applicable
• Format Labeling
• Collect attribute data
• Upload existing data
• Develop process for future products
• Develop processes and procedures for overall system compliance
How is data submitted to GUDID?
• Create an import file for all products
• Determine the method of submission
- Web – Secure on-line entry with an authenticated user account
- File Submission - HL7 Structured Product Labeling Standard for batch
- Hybrid – Batch file submission and on-line update/correction
High Level Task List
Standard and Request Account
- GS1 or HIBCC
- Request DUNS Number
- Request GUDID Account
Assess Product Portfolio - Assess device class and volume, packaging
configuration (QTY, etc.)
- Identify internal and external products
Assess Master Data - Identify data source for all UDI data fields and
correlate with current item master
- Establish Global Medical Device Nomenclature
- Determine how master data will be maintained
accurately going forward
Assess Packaging and Labeling - Determine level of packaging an item will need
to have a UDI
- Determine if Direct Part Marketing will be
- Select Technology Human and/or AIDC
Assess Business Process - Assess operational processes to determine if a
process and/or system change is needed
- Determine if 21CFR Part 11 revalidation will be
• Prepare Master Productlist
• Identify Project Team
• Establish timeline based on product classification
• Present to Business Management
• Identify in detail products and need to up date master
• Set up processes and SOPs
• Modify Labels and related Process
• Implement Database and file submission system
• Perform Validation Activities
• File Submission to GUDID
• Up date SOPs based on test runs/ train user
• Go Live
• Process improvement and feed back
High Level Task List