1. Opal Events: “Medical Devices Summit” in Boston, MA
Unique Device Identification (UDI) Labeling Techniques to Get You Ahead of the Market
Gary Saner
Sr. Manager, Information Solutions - Life Sciences
Opal Events: “Medical Devices Summit” in Boston, MA
February 20, 2015

2. Agenda FDA Unique Device Identifier (UDI) Requirements
Medical Device Manufacturer’s 12 Steps to UDI Compliance
Reference Material

3. FDA UDI Requirements for Medical Devices

4. Background …
“The Food and Drug Administration (FDA) has released a final rule requiring that most medical devices distributed in the United States carry a Unique Device Identifier, or UDI.”
“As part of the UDI system, the FDA is also creating the Global Unique Device Identification Database (GUDID) which will include a standard set of basic identifying elements for each device with a UDI.”

5. FDA’s Purpose and Public Health Benefits of UDI
Medical Device UDI enhances and provides support for:
Global Visibility
Medical Device recalls
Adverse Events Reporting
Tracking and tracing (reduced counterfeiting)
Supply chain security and efficiencies
Reduced medical errors
Post-market surveillance
An easily accessible source of device information for patients, clinicians, and the public

6. Unique Device Identifier (UDI) Definition
A UDI is a unique numeric or alphanumeric code that consists of two parts: Device Identifier (DI) and Production Identifier (PI)
UDI = DI + PI(s)
Device Identifier (DI) – a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device
Production Identifier (PI) – a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of a device:
Lot or Batch Number
Serial Number
Expiration Date
Manufactured Date
Donor Identification Number Distinct identification code required by § (c) for a human cell, tissue, or cellular and tissue-based product (HCT/P) regulated as a device.

7. UDI Regulation Overview
Label
UDI (Device Id + Production Id) on Device Label & Pkg
UDI in plain-text (human readable) and Automatic Id and Data Capture (AIDC) technology (1D/2D barcode, RFID, near-field communication…)
Date Format YYYY-MM-DD ( )
Direct Marking (DM)
Multiple use and reprocessed devices
Permanently mark UDI on device
FDA Global UDI Database (GUDID)
Submit DI and device attributes
Public access, global model
GUDID
Reporting – include UDI as available

8. UDI Compliance Timeline
Reference: FDA UDI website

9. UDI Final Rule Highlights
Label
UDI (DI+PI) required on product label and package in plain text and AIDC format
UDI must use an FDA approved Issuing Agency-Standard (GS1-GTIN, HIBCC-HIBC, ICCBBA-ISBT)
If AIDC is not visible, include a disclosure notice
PI to include Lot/Batch #, Serial #, Mfg Date, Expiration Date, and HCT/P Code if on label
If Manufacturing /Expiration dates are displayed on label other than in UDI, use YYYY-MM-DD format (dates in UDI must use Issuing Agency date format)
UDI required on Unit of Use, Base Product, Level 1 Pkg, Level 2 Pkg up to shipping container
UDI required on stand-alone “device” software (e.g., on About or Help page), downloads exempt from AIDC

10. UDI Final Rule Highlights (continued)
Direct Marking: permanent UDI mark required if multi-use & reprocessed (excludes implants)
“mark” can be a durable label affixed or attached to device or a physical part mark (etch, ball peen, etc.)
“reprocessed” infers a cleaning, wipe down, sterilization, or similar process between patients
GUDID Registry Labelers must submit device DI and attributes to FDA GUDID
FDA GUDID Web Interface
FDA ESG using SPL documents
Medical Device Reporting, Facility Annual Report, etc. UDI must be included in various device reports, if UDI is available
GUDID

11. UDI Final Rule Highlights (continued)
Exceptions and Extensions
General Exception: research (non clinical), investigational, vet device, exports, national stockpile
Inventory Exception: +3 years after Class compliance date
Class III Requested Extension: +1 year, if request (by June 23, 2014) is approved
Class I GMP Exception: UDI not required
Class I PI Exception: No PI component required in UDI
Class I Retail Exception: UPC can be UDI
Single Use Device Exception: if multiple in 1 Pkg (any class/except implants), then UDI required on device package, not required on single use device label
Convenience Kit Exception: UDI required on kit, UDI not required on components
Combination Product Exception: UDI required on product, UDI not required on components (special NDC cases)
Class III Contact Lens and Intraocular Lens Extension: +1 year, Sep 2015
Class II Single-use Implants Sterilized before use Extension: Labeling only +1 year, Sep 2016
All NHRICs and NDCs assigned to devices: rescinded by , request use of labeler code
Manufacturer determines UDI update: based on new version/model number

12. Key FDA UDI Documentation
UDI Rule
Proposed
Amended
Final
Guidance for Industry (GFI)
Recmd
UDI Small Entity Guidance
UDI Issuing Agency Formats
GUDID Draft
Final (1st phase)
Final (complete)
Latest
GUDID Data Elements
Revision (Rules)
SPL Implementation Specification – XML Message Definition
Revision (SPL Folder name, FDA PT, etc.)
Latest
Revision (MRI, DIN, Vocab)
Revision (Rules)
Additional Support
Website, Webinars, Videos, Help Desk, Exceptions, FAQ
Class III Intraocular Lens Extension 2015
Single-use Implant (Sterilized Before Use) Label Extension 2016

13. Medical Device Manufacturer’s 12 Steps for UDI Compliance

14. 12 Steps Summary UDI Prep Create UDI Governance Team
Research/Identify FDA UDI Requirements for Your Products
Evaluate Your Situation
Define and Implement UDI Labeling Plan
Evaluate, Select, and Implement GUDID Solution
Create FDA Accounts (GUDID, ESG)
Collect Source GUDID Data
Normalize and Validate Source GUDID Data
Submit GUDID Data to FDA
Process ACK Messages
Initiate & Maintain Data and System
International Readiness
GUDID Prep
Production

15. Step 1 – Create UDI Governance Team
Analysis, Planning, Roadmap
Product Design
Label, DM
Mfg
Production Control
MDM, Inventory, Supply Chain
Regulatory
Collect and Submit Data to FDA
Marketing
Publish, Order Mgmt
Financial
Funding, Budget
Data is most likely in disparate systems
All data may not be in accessible electronic format

16. Step 2 – Research/Identify FDA UDI Requirements for Your Products
Research FDA UDI Final Rule and Guidance relevant to Your Products
Identify your Product Class(es), Timing/Extensions, Exceptions, Direct Marking, etc.
UDI Final Rule
Final GUDID Guidance for Industry
GUDID Data Elements Reference Table
SPL Implementation Files
Check UDI Activity in Industry Associations

17. Step 3 – Evaluate Your Situation
Evaluate your “Data Situation”
Data location, gaps, owners, formats, etc.
Evaluate Internal Standards
Product Identification / Batch / Serialization
Issuing Agency (GS1, HIBCC, or ICCBBA) for Product Identification
UDI Formats by FDA-Accredited Issuing Agency
Evaluate Systems
Existing MDM, Labeling System, etc.
Existing AIDC Technology (1D, 2D, etc.) for UDI Presentation on Label
Evaluate Processes
Workflow
Compliance Documentation
Training

18. Step 4 – Define and Implement UDI Labeling Plan
Plan and Implement UDI Labeling (and Direct Marking) Process
Revise Production Systems, e.g., MDM, ERP, PLM, Labeling, Inspection, Supply Chain
Initiate Product / Batch / Serialization Identification Process
Select and implement Issuing Agency (GS1, HIBCC, or ICCBBA) standard
Assign Device Identifiers to Products (Primary, Secondary, Unit of Use, Direct Marking, Package Levels)
Assign Production Identifiers to Batch / Lot / Serialization (ensure uniqueness)
Revise Labels:
Add Human Readable UDI, AIDC UDI, and correct Date format to templates
Ensure dynamic data flows from production system to product label
Implement AIDC Technology (1D, 2D, etc.) for UDI Presentation
If Direct Marking is required, implement permanent marking process
Perform necessary System Validation and Training
Create necessary Documentation (DHF, SOPs, Work Instructions, etc.)

19. Step 5a – Evaluate, Select, and Implement GUDID Solution

20. Step 5b – Evaluate, Select, and Implement GUDID Solution Choose Submission Method
* SaaS – Software as a Service

21. Description/Comments FDA GUDID Web Interface
Step 5c – Evaluate, Select, and Implement GUDID Solution Submission Method Comparison
Submission Method
Description/Comments
Technology Cost
Operations Cost
FDA GUDID Web Interface
You (or third party) enter data directly into the FDA GUDID
Best suited for low volume
Transcription error concern
Limited international reuse
“No” software cost
Your admin, data entry, & QA labor
Internal Software
Buy / build / upgrade software (ERP, PLM, MDM, Labeling or other) to collect data and build SPLs
Submit SPLs to FDA via the ESG (AS2)
“Own” software (buy/build/upgrade, install, validate, train, maintain)
ESG account (AS2)
Your admin & operations labor
Hosted Software
(Software as a Service)
Use external software to collect data, build, and submit SPLs to FDA via the ESG
High volume submissions
“Rent” software
Outsourced Service
External provider accepts your data, builds, and submits SPLs to FDA via the ESG on your behalf
“No” internal Admin & operations labor
Service cost
Gray Sheet UDI Article, AS2 - Applicability Statement 2

22. Step 5d – Evaluate, Select, and Implement GUDID Solution Select and Implement Method
Selection Considerations
Solution Capabilities, Expertise, and Experience
SPL Data Validation
Controlled Vocabularies
FDA ESG Submission
ACK Processing and Reporting
On-going Data Management (ease and capability)
“Future Proof”
Scalable
International capabilities
21 CFR Part 11 Compliance (not relevant for FDA GUDID Web Interface)
Cost Effective
Implement Chosen Solution

23. Step 6a – Create FDA Accounts (GUDID, ESG) Request GUDID Account Form
GUDID Pre-Production Account Set Up Process
Request a Pre-Production (Test) GUDID Account Request Form from the FDA

24. Step 6b – Create FDA Accounts (GUDID, ESG) Complete and Submit GUDID Account Form
GUDID Pre-Production Account Set Up Process
Complete the GUDID Account Request Form (Identify Labeler DUNS Numbers / Users / Roles) Attachment to from the FDA (top half of page 1; 3 pages total)

25. Step 6c – Create FDA Accounts (GUDID, ESG) Setup ESG Account
ESG Account Set Up Process (if using SPL Submissions)
Request ESG Test Account
Send Letter of Non-Repudiation
Obtain and Send a Digital Certificate
Register/Launch ESG Test Account
Send Test Submissions (connectivity test, compliance test)
Apply for ESG Production Account
Launch ESG Production Account

26. Step 6d – Create FDA Accounts (GUDID, ESG) Test GUDID Pre-Production Account using ESG Connection
GUDID Pre-Production Account Testing Process (if using SPL Submissions)
Complete 4 Test Scenarios – SPL submission into GUDID

27. Step 6e – Create FDA Accounts (GUDID, ESG) Setup GUDID Production Account
GUDID Production Account Set Up Process
Request a Production GUDID Account using the same process as the Pre-production account
Use the same Application Form as before; make any changes necessary for the GUDID Production environment

28. Step 7a – Collect Source GUDID Data
Collect Source Production GUDID data
Collect data from multiple sources, such as:
Production Systems, e.g., PLM, MDM, ERP
Labeling System (label templates, dynamic data)
Regulatory Systems
If necessary, capture data from Label (e.g., “single use” icon)
Populate (55) GUDID Values into Records
Merge partial records from multiple data sources
If desired, collect additional data fields for your internal purposes and/or future UDI submissions to international Regulatory Authorities

29. Step 7b – Collect Source GUDID Data
GUDID Data (directly)
GUDID Data (needs coding)
Reference: FDA “GUDID GFI” Jun

30. Step 7c – Collect Source GUDID Data
Identification
Pri DI Issuing Agency
Primary DI #
Brand Name
Version/Model #
Catalog #
Device Description
Sec DI Issuing Agency
Secondary DI #
DM Exempt (Y/N)
DM DI Different (Y/N)
DM DI #
Regulatory
Publish Date
Distribution End Date
Distribution Status*
Premrkt Exempt (Y/N)
Premrkt Submission #
Supplement #
FDA Listing #
Product Code
Product Code Name*
GMDN Code
GMDN Name*
GMDN Definition*
Rx (Y/N)
OTC (Y/N)
Packaging
Device Count
Unit of Use DI #
Kit (Y/N)
Pkg DI #
Pkg Quantity
Pkg Contains DI #
Pkg Type
Pkg Discontinue Date
Pkg Status*
Characteristics
Single Use (Y/N)
Combo Product (Y/N)
HCT/P (Y/N)
Contains Rubber (Y/N)
Not Made with Rubber (Y/N)
MRI Safety Info
Size Type
Size Value
Size Unit
Size Text
Storage & Handling Type
S&H Low value
S&H High Value
S&H Unit
Storage Conditions
Sterile Pkg (Y/N)
Sterile Req'd
Sterile Method
Production Control
Lot/Batch (Y/N)
Serial # (Y/N)
Mfg Date (Y/N)
Expiration Date (Y/N)
Donation Id # (Y/N)
Labeler
Labeler DUNS #
Labeler Name*
Labeler Address*
Contact Phone
Contact
55 Submitted by Labeler
(some can have multiple values)
7 Populated by FDA GUDID System
* Populated by FDA GUDID System

31. Step 8a – Normalize & Validate Source GUDID Data
“Normalize” data to FDA GUDID specs
Follow FDA Business Rules. For example:
GS1 GTINs must be 14 numeric characters
Date Format must be YYYY-MM-DD
Where applicable, ensure values utilize Controlled Vocabularies. For example:
“cm” for Size Unit of Measure
“Cel” for Temperature (Degrees Celsius)
For “grouped data,” all necessary related fields must be populated. For example:
Clinically Relevant Size Type = Length
Clinically Relevant Size Value = 25
Clinically Relevant Size Unit = cm
For “dependent data,” all necessary related fields must be populated. For example:
If “Require Sterilization prior to use?” = “Yes,” then “Sterilization Method” must be populated
Validation of all content: the key to accuracy for your SPL submissions to the FDA
“Problematic” Data Elements from our experience. For example:
Labeler DUNS Numbers
Device Identifiers assignment
GMDN or FDA Preferred Term Values
Packaging and Kit Configurations

32. Step 8b – Normalize & Validate Source GUDID Data
GUDID Data Record
55 Submitted Data Elements
Product ID Elements (Pri DI, Sec DI, UoU DI, DPM DI, GMDN)
Regulatory Elements (FDA Listing #, Auth. #, ProCode)
Labeler and Contacts
Characteristics (Sterile, Size, Production Control)
Package Elements (Pkg DI, Qty)
RT GUDID Record Template provided by request

33. Step 9 – Submit GUDID Data to FDA
“Go Live” – Submit Production Device Records
For Manual, Individual Record Entry:
Enter data via FDA GUDID Web Interface
Perform QC on Data Entry
For Automated, Bulk Entry:
Create fully-valid SPL UDI submissions per FDA business rules
Validate SPL XML per FDA schema requirements
Submit SPL UDIs to FDA via ESG
WebTrader – record-by-record manually driven process
AS2 (Applicability Statement 2) – communication protocol for automated bulk transfer

34. Step 10 – Process ACK Messages
Applicable to SPL Submissions only
Monitor and Collect FDA ACK messages
ACK 1 – FDA receipt confirmation
ACK 2 – CDRH receipt confirmation
ACK 3 – CDRH validation results
Pass
Fail, explanatory error message provided
Report ACKs
Indicate GUDID Record Publication Status
Unpublished
Published, in Grace Period
Published
Retired (product taken off market)

35. Step 11 – Initiate & Maintain Data and System
Start Manufacturing
Confirm Device Record is Published in GUDID
Cutover process to include UDI on Label (with direct marking where applicable)
Manage existing Inventory within 3 year allowed window
Flow DI and PI from production systems to labels
Data Maintenance
Update/retire Device Labels and GUDID records as appropriate
Add Device Labels and GUDID records for new products
System Maintenance (for in-house software only)
Update, Validate, Train, and Document system changes
Knowledge Maintenance
Monitor and Implement changing FDA Regulations and Guidance (subscribe to FDA UDI/GUDID notifications)

36. Step 12 – International Readiness
International Medical Devices Regulatory Forum (IMDRF)
Cornerstone of global medical device regulatory direction
Group of Medical Device Regulators (Australia, Brazil, Canada, China, EU, Japan, Russia, U.S.)
A single worldwide UDID will not be implemented
Per Laurent Selles, Senior Coordinator for International Relations, EC; Munich, May 2014
Regional UDIDs will contain core information and have varying regional content.
“Convergence, not Harmonization”
EU Late 2015 / most likely 2016 – EU UDI Mandate
Other regulatory authorities actively involved in UDI EU
Asia (China, Japan, Korea, Singapore)
Australia
Canada
South America (Brazil, Argentina)

37. Reed Tech Contact Information
Web:
Phone: or
Address: 7 Walnut Grove Drive, Horsham, PA, USA
Gary Saner Sr. Manager, Information Services – Life Sciences

38. Reference Material

39. Reed Tech UDI Resources
Available from ReedTech.com:
GUDID Readiness Kit
Reed Tech GUDID Data Element List
Multiple Options To Weigh For Moving A UDI Into FDA’s Database “The Gray Sheet”  6 January  2014
UDI Training Course (in collaboration with Lernia Training Solutions)
Available Upon Request:
Sample GUDID Account Request Form
Reed Tech GUDID Record Template

40. UDI Resources FDA UDI “Home Page” UDI Help Desk GUDID Information
UDI Rule, GUID Guidance, Compliance Dates, Resources
UDI Help Desk
GUDID Information
Basics, Guidance, Account Request, GUDID Web Interface, HL7 SPL, GUDID Status
GUDID Web Interface (Login)
CDRH Resources (FDA Presentations: GUDID overview, account setup, etc.)
IMDRF –
EC Medical Devices –

41. Medical Device UDI Glossary
AIDC Automatic Id and Data Capture – technology used for automated product identification (typically 1D/2D barcode, RFID, near-field communication, etc.) DI Device Identifier – static product identification (uniquely identifies company and product version) ESG Electronic Submissions Gateway – FDA agency-wide secure solution for accepting electronic regulatory submissions in electronic, bulk format GUDID FDA Global UDI Database – registry of Medical Device DI and attributes GS1 GS1 – an international, not-for-profit association that develops global standards (e.g., Global Trade Item Number-GTIN and Application Identifiers-AI) to improve the efficiency and visibility of supply and demand chains across sectors; Issuing Agency FDA approved agency (standard) used to represent Medical Device UDI (GS1, HIBCC, and ICCBBA) HIBCC Health Industry Business Communications Council – a non-profit organization that develops electronic exchange standards (e.g., Health Industry Bar Code-HIBC) for health care trading partners; HL7 Health Level Seven – standards developing organization providing international healthcare information system interoperability standards for the exchange, integration, sharing, and retrieval of information ICCBBA International Council for Commonality in Blood Banking Automation – international standards organization (not-for-profit, nongovernmental) responsible for the ISBT 128 Standard (International Standard for Blood and Transplant); PI Production Identifier – dynamic manufacturing information (i.e. batch/lot #, serial #, mfg. date, expiration date, and HCT/P code) SPL Structured Product Labeling – document markup standard (XML) approved by HL7 and adopted by FDA as a mechanism for exchanging product information UDI Unique Device Identifier = Device Identifier (DI) + PI (Production Identifier) per approved Issuing Agency XML Extensible Markup Language – markup language defining a set of rules for document encoding in both human and machine readable language.

42. Global UDID Data Elements