www.ReedTech.com +1‐800‐772‐8368

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Agenda

Reed Tech Company Profile

FDA Unique Device Identifier (UDI) Requirements

Medical Device Manufacturers’ GUDID Challenges

Reed Tech GUDID Submission Solution

Q&A

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Questions

Please send questions during the session via webinar “Chat”

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Reed Tech Company Profile

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Reed Tech Profile

Over 50 years of experience; founded in 1961

Over 900 employees 

Part of the LexisNexis family; a business unit of Reed Elsevier

Contractor to USPTO to process all patent applications and grants

Service Provider to over 700 Life Sciences companies

A recognized leader in providing solutions for content and lifecycle management

Certified to ISO 9002 in 1998Upgraded to ISO 9001:2008 in 2008

HL7 Organization Member since 2005

Philadelphia HeadquartersHorsham, PA, USA

Washington OperationsAlexandria, VA, USA

www.ReedTech.com 6

Reed Tech – Life Sciences Services

Structured Product Labeling (SPL)Preparation, Submission, and Lifecycle Management

• Service provider for over 700 life sciences companies6 of 10 largest pharma manufacturers in the world; large (200+ labels) to small (1 label)Over 26,000 SPLs created since FDA drug mandate in 2005Most experienced SPL service provider in the industry

• FDA Electronic Submissions Gateway (ESG) serviceHighest volume submitter of SPLs (over 13,000) Over 375 companies

SPL

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Reed Tech – Life Sciences Services (continued)

Structured Product Labeling (SPL)Preparation, Submission, and Lifecycle Management

• Expertise in all CDER, CBER, and CVM Drug SPL typesBranded/Generic; Rx/OTCSPL Original/PLR, R3/R4/R5, LCR/ER/SID/LLHuman Health, Biologics/Vaccines, Animal Health, etc.

• Services for CDRH Medical Device UDI SPL (and IFU SPL)Analysis, Data Aggregation, and Data ValidationSPL Build, Submission, and Change ManagementParticipated in FDA SPL‐UDI pilot submission program (Oct 2012)

SPL

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FDA UDI Requirements for Medical Devices

Please send questions during the session

to “Staff” via webinar “Chat”

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FDA’s Purpose and Public Health Benefits of UDI

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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UDI Implementation Timeline

Key FDA Actions2013-09-24 FDA released UDI Final Rule and

Draft GUDID Guidance for Industry (database definition)2013-11-?? Awaiting GUDID SPL Implementation Specification (SPL XML message definition).

Delay is due to federal government shutdown.2013-11-25 Comment period for Draft GUDID Guidance for Industry will end. Final GFI TBD.

Reference: FDA UDI website

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Direct Part Marking (DPM)Permanently mark UDI on device itselfMultiple use and reprocessed devices

LabelingUDI (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…• If AIDC is not visible, add disclosureDate Format YYYY-MM-DD (2013-10-29)UDI on “Device” Software

UDI Regulation Overview

FDA Global UDI Database (GUDID) (“Good-I-D”)

Submit DI and device metadataPublic access, global model

GUDID

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Final Rule Highlights

Device Packages:  UDI required on Unit of Use, Base Product, Level 1 Pkg, Level 2 Pkg up to Shipping Container

Single Use Device Exception (multiple in 1 Pkg, any class/except implants): UDI required on device package, not required on device labelConvenience Kits: UDI required on kit, UDI not required on componentsCombination Product: UDI required on product, UDI not required on components (special NDC cases)Inventory Exception: +3 years after Class compliance dateClass III Extension: +1 year, if request is approved Manufacturer determines UDI update: based on new version/model numberMedical Device Reporting, Facility Annual Report: must include UDI

More items in Appendix

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Medical Device Manufacturers’ GUDID Submission Challenges

Please send questions during the session

to “Staff” via webinar “Chat”

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UDI Implementation Challenges

UDIGovernance

Analysis, Planning, Roadmap

ProductDesignLabel, DPM

ManufacturingRevised Label,

DPM

ProductionControlMDM,

Inventory, Supply Chain

RegulatoryCollect and

Submit Data to FDA

MarketingPublish,

Order Mgmt

FinancialFunding, Budget

Data is most likely in disparate systems

All data may not be in accessible electronic format

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Results of Attendees Survey

Q1 - Estimate the total number of product SKUs you need to submit to the FDA for all classes. (309 responses)

37%

26%

9%

3%

26%

Not started

Planning started

Identification, etc. underway

Identification, etc. completed

Uncertain or Not Applicable

0% 20% 40%

12%

4%

4%

14%

65%

Use internally developed toolUse purchased softwareUse a service provider

Use the FDA GUDID web toolUncertain or Not Applicable

0% 20% 40% 60% 80%

41%11%12%

3%2%2%

28%

< 100101 – 1,000

1,001 – 10,00010,001 – 50,00050,001 – 100,000

> 100,000Uncertain or Not Applicable

0% 20% 40% 60%

29%

64%

40%

21%

Class IIIClass IIClass I

Uncertain or Not Applicable

0% 20% 40% 60% 80%

Q3 - How far along are you in identifying, collecting and organizing the UDI data that you will need to submit to the FDA? (309 responses)

Q4 - What method would you prefer to use to submit your UDI data to the FDA? (307 responses)

Q2 - What device classes does your organization manufacture (select all that apply)? (474 responses)

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GUDID Data Collection and Submission Steps

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GUDID Data Submission Plans

1. Evaluate your “data situation” (location, gaps, owners, formats, etc.)

2. Determine your best GUDID data submission method/tool3. Collect, Normalize, and Validate source GUDID data

• If necessary, capture data from Label (e.g., single use icon)• If desired, collect additional data fields for future UDI submissions to 

international Regulatory Authorities and/or your internal purposes• Merge partial records from multiple “data sources”• “Normalize” data to FDA GUDID specs 

(e.g., Business Rules, Controlled Vocabularies)

4. For Manual Entry: enter data via FDA GUDID Tool5. For Automated Entry:

• Create fully‐valid SPL UDI submissions per FDA business rules• Submit SPL UDIs to FDA via ESG (AS2)

6. Submit changes/revisions

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GUDID Data Record

GUDID Data RecordApproximately 55 Fields

Product ID Elements (Pri DI, Sec DI, UoU DI, DPM DI, GMDN)Regulatory Elements(FDA Listing #, Auth. #, ProCode)Labeler and ContactsCharacteristics (Sterile, Size, Production Control)Package Elements (Pkg DI, Qty)…

Reference: Appendix B, Draft GUDID Guidance for Industry

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GUDID Data Submission OptionsSubmission

Method Description/Comments Technology Cost Operations Cost

FDA GUDID Tool

• You (or third party) enter data directly into the FDA GUDID

• Transcription error concern• Low volume

• “No” tool cost• Admin, data entry

& QA labor (yours or third party)

Outsourced Service

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

• “No” tool cost• “No” Admin &

operations labor• Service cost

SaaS(Software asa Service)

• Use external tool to collect data,build and submit SPLs to FDA via the ESG

• “Rent” tool • Admin & operations labor

UDI Software

Utility

• Buy / build / upgrade an internal tool (ERP, PLM, MDM, Labeling or other) to collect data and build SPLs

• Submit SPLs to FDA via the ESG (AS2)

• “Own” tool (buy/build/upgrade, install, validate, train, maintain)

• ESG account (AS2)

• Admin & operations labor

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Reed Tech GUDID SPL Submission Solution (SaaS or Outsourced)

Please send questions during the session

to “Staff” via webinar “Chat”

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Reed Tech GUDID SPL Solution (SaaS or Outsourced)

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Reed Tech UDI Solution Benefits

Simple – minimal change to your current processesLeast intrusive – supply data from your existing systems, initially and for subsequent, on‐going maintenanceCost effective – save IT costs (hardware and software purchase, installation, validation, and maintenance) Leverage Reed Tech's significant SPL preparation and ESG submissions experience• Over 26,000 SPLs created for over 700 customers• Over 13,000 ESG submissions for over 375 companies• Participated in FDA SPL‐UDI pilot submission program (Oct 2012); 

only company whose SPLs passed validation

Gain an experienced corporate partner – over 50 years of knowledge and expertise in data collection, content conversion, lifecycle management, and excellent customer service

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Q&A

Please send questions

to “Staff” via webinar “Chat”

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Reed Tech Contact Information

Gary Saner Sr. Manager, Information Solutions – Life SciencesMark Bayer VP, Business Development

Haley Lentz Account Executive, Life Sciences

Web:  www.ReedTech.com 

Email: hlentz@reedtech.com

Phone: +1‐800‐772‐8368

www.ReedTech.com 25

Appendix – Additional Final Rule Highlights

Label• UDI (DI+PI) required on label and package in plain text and AIDC format • If AIDC is not visible, use disclosure (not the proposed AIDC symbol) • If Mfr/Expiration dates are displayed, use YYYY‐MM‐DD format and include dates in PI

Direct Part Marking: permanent UDI required, if multi‐use & reprocessed (not implants)

GMDN GUDID terms: freely available from FDA

All NHRICs and NDCs assigned to devices: rescinded by 2018‐09‐24, able to request use of legacy labeler code

Broad Exceptions: research (non clinical), investigational, vet device, exports, national stockpileStand‐alone Software: UDI required, downloads exempt from AIDC

Class I GMP Exception: UDI not requiredClass I Exception: No PI requiredClass I Retail Exception: UPC can be UDI…