www.ReedTech.com 1www.ReedTech.com +1‐800‐772‐8368

www.ReedTech.com 2

Agenda

Reed Tech Company Profile

FDA Unique Device Identifier (UDI) Requirements

Medical Device Manufacturers’ GUDID Challenges

Reed Tech GUDID Submission Solution

Q&A

Appendix

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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 725 Life Sciences companies

A recognized leader in providing solutions for content and lifecycle management

ISO Certified since 1998 (9001:2008)

HL7 Member since 2005

Philadelphia HeadquartersHorsham, PA, USA

Washington OperationsAlexandria, VA, USA

GS1 Solution Partner

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Reed Tech – Life Sciences Services

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

• Service provider for over 725 life sciences companies6 of 10 largest pharma manufacturers in the world; large (200+ labels) to small (1 label)Over 28,000 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 14,000) Over 400 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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UDI Implementation Timeline

Key FDA Documents2013-09-24 UDI Final Rule and

Draft GUDID Guidance for Industry (database definition)2013-11-21 Draft GUDID SPL Implementation Specification (SPL XML message definition)2014-02-13 Revised Draft GUDID SPL Implementation Spec (folder name, FDA PT Code)TBD Final GUDID GFI and Final GUDID SPL Implementation Spec

Reference: FDA UDI website

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

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)Submit DI and device attributesPublic access, global model

GUDID

Reporting – include UDI as available

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UDI on Label vs. GUDID Submission Data

Definitions• UDI = DI + PI(s)• GUDID Data = DI (not PI) + Device Attributes = 55 Submitted Fields

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GUDID Data From Label

Reference: Indira Konduri, FDA, “The GUDID Account,” webinar Jan 30 2014

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GUDID Data Elements

55 Submitted by Labeler(some can have multiple values)

7 Populated by FDA GUDID System (indicated by *)

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GUDID Data Record

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 ContactsCharacteristics (Sterile, Size, Production Control)Package Elements (Pkg DI, Qty)

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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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If yes, which of the following methods do you prefer? (286 responses)

Have you decided what method you will use to submit your UDI data to the GUDID?(474 responses)

If you are submitting Class III UDI data to the FDA, and taking into consideration the September 24, 2014 deadline, when are you anticipating making your submissions? (369 responses)

Results of Attendees Survey

How far along are you in identifying, collecting and organizing the UDI data that you will need to submit to the FDA?(407 responses)

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GUDID Data Submission Methods

* SaaS – Software as a Service

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GUDID Data Submission Methods 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

• “No” software cost• Admin, data entry,

& QA labor (yours or third party)

Hosted Software

(Software as a Service)

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

• High volume, electronic submissions

• “Rent” software • Admin & operations labor

Outsourced Service

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

• “No” software cost• “No” Admin &

operations labor• Service cost

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)

• Admin & operations labor

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GUDID Submission Method Evaluation

Selection Criteria• Determine Submission Data Location and Management

Data Entry, Hosted, Outsourced, or Internal 

• Need 21 CFR Part 11 Compliance (for non‐FDA GUDID Tools)Device Labeler is responsible3rd Party organization is not directly responsible

• Consider Solution Capabilities and ExpertiseSPL Data ValidationControlled VocabulariesFDA ESG Submission ACK Processing and ReportingMaintenance

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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 Complements your current internal processes

Least intrusive Accepts data from your existing systems, initially and for subsequent, on‐going maintenance • Flexible data import options: manual entry, text file, XLS, XML• Data Transformations available per Reed Tech Synonym Vocabulary• Data Collection assistance available

Cost effective • Efficient, automated, bulk submissions • Save IT costs (e.g., hardware/software purchase, installation, validation, 

maintenance) 

Flexible UDI solution• Accommodates additional custom/proprietary data fields beyond FDA 

requirements• Easy expansion for future UDI submissions to global regulatory authorities

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Reed Tech UDI Solution Benefits (continued)

Compliant (21 CFR Part 11) preparation & submission to FDA • Role‐based data management and approvals• Preparation, submission, and acknowledgement reporting

Leverage Reed Tech's significant SPL preparation and ESG submission experience• Over 28,000 SPLs created for over 725 customers• Over 14,000 ESG submissions for over 400 companies• Participated in FDA SPL‐UDI pilot submission program (Oct 2012); 

only company whose SPLs passed validation

Gain an experienced corporate partnerOver 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 DevelopmentHaley Lentz Account Executive, Life Sciences

Web:  www.ReedTech.com 

Email: hlentz@reedtech.com

Phone: +1‐800‐772‐8368

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Reed Tech UDI Resources

Free upon request:Reed Tech GUDID Data Element List and Record TemplateMultiple Options To Weigh For Moving A UDI Into FDA’s Database“The Gray Sheet”  January 6, 2014UDI Training Course • Interactive eLearning Course• Collaborative with Lernia Training Solutions: www.Lernia‐ts.com

Contact: Haley Lentz Account Executive, Life Sciences

Email: hlentz@reedtech.com

Phone: +1‐800‐772‐8368

Web:  www.ReedTech.com 

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FDA UDI Resources

UDI “Home Page”• UDI Rule, GUID Guidance, Compliance Dates, Resources• http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIde

ntification/default.htm

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

ntification/ucm368904.htm

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

ntification/GlobalUDIDatabaseGUDID/default.htm

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

CDRH Learn (FDA Presentations)• UDI System – The Final Regulation• GUDID Overview (with UDI Introduction)• GUDID ‐ Account Set‐up• http://www.fda.gov/Training/CDRHLearn/ucm162015.htm#udi

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GUDID Data Collection and Submission Steps

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GUDID Data Submission Plans1. 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

• Collect data from multiple sources; generate values as required• 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. Create FDA GUDID Account5. Submit Data• For Manual, Individual Record Entry: enter data via FDA GUDID Web Interface

• For Automated, Bulk Entry:Create fully‐valid SPL UDI submissions per FDA business rulesSubmit SPL UDIs to FDA via ESG (WebTrader, AS2)

6. Submit changes/revisions and new device records

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Final Rule Highlights

Label• UDI (DI+PI) required on product label and package in plain text and AIDC (e.g., bar code) format • Labeler creates UDI per FDA‐approved Issuing Agency specs (GS1, HIBCC, or ICCBBA)• If Lot/Batch #, Serial #, Mfg date, Expir date, or HCT/P code appear on label, include each in PI• If Mfg/Expiration dates are displayed on label, use YYYY‐MM‐DD format 

(AIDC date format can be different)• If AIDC is not visible, use disclosure statement (not proposed AIDC symbol) • If device is Stand‐alone Software, UDI required (on About or Help page), downloads exempt from 

AIDC• Different UDI required on Unit of Use, Base Product/Pkg, Level 1 Pkg, Level 2 Pkg, up to Shipping 

Container

Direct Marking: if multi‐use & reprocessed (not implants), permanent UDI is required • “reprocessed” infers a cleaning, wipe down, sterilization, or similar process between patients• “mark” can be a durable label affixed or attached to device or a physical part identification 

(engraving, etching, ball peen, etc.)

GUDID: submit device DI+ Attributes to FDA GUDID by Class Compliance Dates

Reporting: if UDI is available, include in Medical Device Reporting, Facility Annual Report, etc.

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Final Rule Highlights (continued)

Broad Exceptions: research (non clinical), investigational, vet device, exports, national stockpileInventory Exception: +3 years after Class compliance date

Class III Extension: +1 year, if request (by June 23, 2014) is approved Class I GMP Exception: UDI not requiredClass I Exception: No PI requiredClass 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)

GMDN Code: temporary FDA Preferred Term code (4 characters) is freely available from FDA GUDID Web Interface, actual GMDN Code (5 characters) is eventually needed

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

UDI Updates: Manufacturer determines updates based on new version/model number