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Unique Device Identification (UDI)Labeling Techniques

to Get You Ahead of the Market

Gary SanerSr. Manager, Information Solutions - Life Sciences

gsaner@reedtech.com, +1-610-731-7192

Opal Events: “Medical Devices Summit” in Boston, MAFebruary 20, 2015

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Agenda

FDA Unique Device Identifier (UDI) Requirements

Medical Device Manufacturer’s 12 Steps to UDI Compliance

Reference Material

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FDA UDI Requirements for Medical Devices

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Background

2013-09-24…

“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.”

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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

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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 §1271.290(c) for a human cell, tissue, or cellular and tissue-based product (HCT/P) regulated as a device.

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Direct Marking (DM) Multiple use and reprocessed devices Permanently mark UDI on device

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 (2013-09-24)

UDI Regulation Overview

FDA Global UDI Database (GUDID) Submit DI and device attributes Public access, global model

GUDID

Reporting – include UDI as available

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UDI Compliance Timeline

Reference: FDA UDI website

Class IClass II

Compliance Timeline for UDI Implementation

Class IClass IIILL2Class IIIGUDID data

submitted to FDA and UDI on Label

UDI

Direct Marking3 Class III

1) FDA UDI Final Rule published 2013-09-242) ILL = Implantable, Life-supporting, and Life-sustaining devices3) Direct Marking required on multiple-use and reprocessed devices

2014-09 2015-09 2016-09 2018-09Final Rule1

2020-09

ILL2

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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

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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

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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 2018-09-24, request use of labeler code

Manufacturer determines UDI update: based on new version/model number

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Key FDA UDI Documentation

2014-08-13 UDI Small Entity Guidance

SPL Implementation Specification – XML Message Definition

2013-09-24 GUDID Draft

2014-02-13 Revision (SPL Folder name, FDA PT, etc.)

2014-04-14 Revision (MRI, DIN, Vocab)

Guidance for Industry (GFI)

2013-11-21

UDI Rule 2012-07-10 Proposed

Additional Support Website, Webinars, Videos, Help Desk, Exceptions, FAQ

2014-06-11 Final (1st phase) 2014-06-27 Final (complete)

Lates

t2015-01-14 Revision (Rules)

2013-09-24 Final2012-11-19 Amended

2014-05-07 GUDID Data Elements

2014-05-07 UDI Issuing Agency Formats

2015-01-13 Revision (Rules)

2014-08-15 Class III Intraocular Lens Extension 2015

2014-11-19 Single-use Implant (Sterilized Before Use) Label Extension 2016

Lates

t

Recmd

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Medical Device Manufacturer’s 12 Steps for UDI Compliance

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12 Steps Summary

1. Create UDI Governance Team 2. Research/Identify FDA UDI Requirements for Your Products3. Evaluate Your Situation4. Define and Implement UDI Labeling Plan

5. Evaluate, Select, and Implement GUDID Solution6. Create FDA Accounts (GUDID, ESG) 7. Collect Source GUDID Data8. Normalize and Validate Source GUDID Data

9. Submit GUDID Data to FDA10. Process ACK Messages 11. Initiate & Maintain Data and System 12. International Readiness

UDI Prep

GUDID Prep

Production

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Step 1 – Create UDI Governance Team

UDI Governance

Analysis, Planning, Roadmap

Product Design

Label, DM

MfgLabel,

DM

Production Control

MDM, Inventory,

Supply ChainRegulatoryCollect and

Submit Data to FDA

MarketingPublish, Order Mgmt

Financial Funding,

Budget

Data is most likely in disparate systems

All data may not be in accessible electronic format

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Step 2 – Research/Identify FDA UDI Requirements for Your Products

Research FDA UDI Final Rule and Guidancerelevant 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

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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

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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.)

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

XML

TXT

SPL

UDI Data ~~~~~~~~~~~~~~~

ACK

FDA

Data Submission to FDA &

ACK Response

FDA Tool Entry

or SPL-UDI

Build

Data Normalization& Validation

Data Collection

Multiple Storage Locations &

Formats

GUDID

FDA GUDID Tool ~or~

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Step 5b – Evaluate, Select, and Implement GUDID Solution Choose Submission Method

* SaaS – Software as a Service

Medical Device

Manufacturer FDA GUDID Web Interface

GUDIDDB

DB

SPL

SPL

SPL

Admin

Manual Data Entry

GUDID Submission

Data

DB

Software Buy / Build /

Upgrade

Outsourced Service

Hosted Software(SaaS)

Admin

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Step 5c – Evaluate, Select, and Implement GUDID Solution Submission Method ComparisonSubmission

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 • Your admin &

operations labor

Outsourced Service

• External provider accepts your data, builds, and submits SPLs to FDA via the ESG on your behalf

• “Rent” software

• “No” internal Admin & operations labor

• Service cost

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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

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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

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/GlobalUDIDatabaseGUDID/default.htm#account

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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 email from the FDA (top half of page 1; 3 pages total)

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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

http://www.fda.gov/esg

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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 GUDIDhttp://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/GlobalUDIDatabaseGUDID/UCM376009.zip

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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

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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

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Step 7b – Collect Source GUDID Data

Reference: FDA “GUDID GFI” Jun 27 2014GUDID Data (directly)

GUDID Data (needs coding)

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Step 7c – Collect Source GUDID Data

55 Submitted by Labeler(some can have multiple values)

7 Populated by FDA GUDID System

IdentificationPri DI Issuing AgencyPrimary DI #Brand NameVersion/Model #Catalog #Device DescriptionSec DI Issuing AgencySecondary DI #DM Exempt (Y/N)DM DI Different (Y/N)DM DI #LabelerLabeler DUNS #Labeler Name*Labeler Address*Contact PhoneContact Email

RegulatoryPublish DateDistribution End DateDistribution Status*Premrkt Exempt (Y/N)Premrkt Submission #Supplement #FDA Listing #Product CodeProduct Code Name*GMDN CodeGMDN Name*GMDN Definition*Rx (Y/N)OTC (Y/N)

PackagingDevice CountUnit of Use DI #Kit (Y/N)Pkg DI #Pkg QuantityPkg Contains DI #Pkg TypePkg Discontinue DatePkg Status*

Production Control

Lot/Batch (Y/N)Serial # (Y/N)Mfg Date (Y/N)Expiration Date (Y/N)Donation Id # (Y/N)

CharacteristicsSingle Use (Y/N)Combo Product (Y/N)HCT/P (Y/N)Contains Rubber (Y/N)Not Made with Rubber (Y/N)MRI Safety InfoSize TypeSize ValueSize UnitSize TextStorage & Handling TypeS&H Low valueS&H High ValueS&H UnitStorage ConditionsSterile Pkg (Y/N)Sterile Req'dSterile Method

* Populated by FDA GUDID System

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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

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Step 8b – Normalize & Validate Source GUDID Data

GUDID Data Record55 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)

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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

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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)

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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 email notifications)

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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)

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Reed Tech Contact Information

Gary Saner Sr. Manager, Information Services – Life Sciencesgsaner@reedtech.com

+1-610-731-7192

Web: www.ReedTech.com

Phone: 1-800-772-8368 or +1-215-441-6438

Address: 7 Walnut Grove Drive, Horsham, PA, USA

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Reference Material

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Reed Tech UDI Resources

Available from ReedTech.com: GUDID Readiness Kit

http://go.reedtech.com/download-free-ebook-udi-readiness-kit Reed Tech GUDID Data Element List

http://go.reedtech.com/62-elements Multiple Options To Weigh For Moving A UDI Into FDA’s Database

“The Gray Sheet” 6 January 2014http://go.reedtech.com/gray-sheet-article-0

UDI Training Course (in collaboration with Lernia Training Solutions)https://secure.trainingcampus.net/uas/modules/trees/windex.aspx?rx=lernia-udi.trainingcampus.net

Available Upon Request: Sample GUDID Account Request Form Reed Tech GUDID Record Template

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UDI ResourcesFDA UDI “Home Page”

• UDI Rule, GUID Guidance, Compliance Dates, Resources• http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIden

tification/default.htm

UDI Help Desk• http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIden

tification/ucm368904.htm

GUDID Information• Basics, Guidance, Account Request, GUDID Web Interface, HL7 SPL, GUDID Status• http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIden

tification/GlobalUDIDatabaseGUDID/default.htm

GUDID Web Interface (Login)• https://gudid.fda.gov/gudid/

CDRH Resources (FDA Presentations: GUDID overview, account setup, etc.)• http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdent

ification/ChangesbetweenUDIProposedandFinalRules/default.htm

IMDRF – www.imdrf.org EC Medical Devices – http://ec.europa.eu/health/medical-devices

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Medical Device UDI GlossaryAIDC 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 attributesGS1 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; www.gs1us.org

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; www.hibcc.orgHL7 Health Level Seven – standards developing organization providing international healthcare information

system interoperability standards for the exchange, integration, sharing, and retrieval of informationICCBBA 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); www.iccbba.org

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 AgencyXML Extensible Markup Language – markup language defining a set of rules for document encoding in both

human and machine readable language.

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Global UDID Data Elements