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www.ReedTech.com 1www.ReedTech.com 1‐800‐772‐8368 / +1‐215‐441‐6438
www.ReedTech.com 2
Agenda
Reed Tech Company Profile
FDA UDI / GUDID Refresher
12 Steps for Accurate GUDID Submissions
Reed Tech GUDID Submission Solution Overview
Q&A
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Questions
Please send questions during the session to “Staff” 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
Part of the LexisNexis family; a business unit of Reed Elsevier
Over 900 employees
Contractor to USPTO to process all patent applications and grants
Service Provider to over 800 Life Sciences companies, pharmaceutical and medical devices
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
www.ReedTech.com 6
Reed Tech – Pharma ServicesSPL Preparation, Submission, and Lifecycle Management for Drug Establishment Registration and Drug Product Labeling/Listing
• Service provider for over 800 pharma companies4 of the 5 largest pharma manufacturers in the world; large (200+ labels) to small (1 label)Over 33,000 SPLs created since FDA drug mandate in 2005Most experienced SPL service provider in the industry
• Global customersOver 70 companies in over 25 countries outside the U.S.
• FDA Electronic Submissions Gateway (ESG) serviceESG WebTrader and AS2 connectionsHighest volume submitter of pharma SPLs (over 15,000) Over 450 companies
• Experts in CDER, CBER, and CVM Drug SPLs Data Transformation/ValidationSPL Build, ESG Submission, and FDA AcknowledgementSPL Lifecycle Management
SPL
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Reed Tech – Medical Device ServicesSPL Preparation, Submission, and Lifecycle Management forMedical Device product publication in FDA’s GUDID
• GUDID solution provider for over 25 manufacturers (to date)1 of the 3 largest Medical Device manufacturers in the world
• Submitted over 6,700 Class III SPL records to the GUDID (to date)100% acceptance (comprehensive pre‐submission quality check)~20% of total GUDID records (~33,000)*~34% of total GUDID records via SPL (~20,000)*
• Current contracts to submit over 500,000 additional SPL records (to date)(Implantable/Life‐sustaining/Life‐supporting, Class II, Class I)
• Experts in CDRH Medical Device UDI SPLAnalysis, Data Aggregation/Transformation/ValidationSPL Build, ESG Submission, and FDA AcknowledgementGUDID Data Life Cycle Management (SaaS and Outsourced model)
SPL
* Calculations based upon FDA statistics presented at Clarion UDI Conference, Baltimore, 28 Oct 2014
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Reed Tech – Medical Device Services (continued)
• FDA Electronic Submissions Gateway (ESG) serviceParticipated in FDA Pilot Submissions Program in 2014 to assistagency in high volume GUDID ESG load testing ESG AS2 connection for automated, bulk SPL submissionsFDA Acknowledgment reportingGUDID Publication status (unpublished, grace period, published, off market)
• Global RoadmapSupport customers’ needs for international UDID submissions as mandatedReed Tech System is designed to readily accommodate:
Expanded data set of IMDRF and regional UDID attributes Building UDI submissions per regional specificationsSubmitting to international regulatory agencies
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FDA UDI / GUDID Refresher
Please send questions during the session
to “Staff” via webinar “Chat”
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Direct Marking (DM)Multiple use and reprocessed devicesPermanently mark UDI on device
LabelUDI (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 (2013-09-29)
FDA 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 = Device Identifier + Production Identifier(s) = DI + PI(s) • GUDID Data = DI (not PI) + Device Attributes = 55 Submitted Fields
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FDA UDI Compliance Timeline
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Recent UDI Regulatory NewsFDA Advice to Industry • FDA GUDID Guidance for Industry
“Structured input via the GUDID Web Interface – requires manual data entry and is geared for low volume submitters.”“Health Level 7 (HL7) Structured Product Labeling (SPL) submission via the FDA Electronic Submissions Gateway (ESG) – allows for submission via xml files and is geared for high volume submitters.”
• Indira Konduri: “Build data quality into all tenets of your process as you get organized for GUDID submission.”
FDA Industry Letter Dated 2015‐01‐15• “FDA’s experience and feedback from industry indicate that device labelers often take a
number of actions related to organizing, collecting and validating data—before they get a GUDID account or submit device identifier (DI) records. We strongly encourage all device labelers to take such actions to ensure their readiness to meet UDI requirements and streamline the GUDID submission process.”
• FDA to accept GUDID account requests for “I/LS/LS” Labelers on 2015‐01‐26 (Class II later in 2015)
FDA UDI Extensions • Single Use Implants that are sterilized before use
1 year Label Extension to 2016‐09‐24; GUDID Submission date remains 2015‐09‐24
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12 Steps for Accurate GUDID Submissions
Please send questions during the session
to “Staff” via webinar “Chat”
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If you are submitting I/LS/LS UDI data to the FDA, and taking into consideration the September 24, 2015 deadline, when are you anticipating making your submissions? (268 responses)
Survey Results – Your GUDID Submission StatusHow far along are you in identifying, collecting and organizing the UDI data that you will need to submit to the FDA GUDID?(286 responses)
What device classes does your organization manufacture (select all that apply)?(286 responses)
If you are submitting Class II UDI data to the FDA, and taking into consideration the September 24, 2016 deadline, when are you anticipating making your submissions?(239 responses)
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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
pUDI Prep
pGUDID Prep
Production
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Step 1 – Create UDI Governance Team
UDIGovernance
Analysis, Planning, Roadmap
ProductDesignLabel,
DM
MfgLabel,
DM
ProductionControlMDM,
Inventory, Supply ChainRegulatory
Collect 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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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 ProcessSelect and implement Issuing Agency (GS1, HIBCC, or ICCBBA) standardAssign Device Identifiers to Products (Primary, Secondary, Unit of Use, Direct Marking, Package Levels) Assign Production Identifiers to Batch / Lot / Serialization (ensure uniqueness)Implement AIDC Technology (1D, 2D, etc.) for UDI Presentation
• Revise Labels: add Human Readable UDI, AIDC UDI, and Dates to templates• Ensure dynamic data flows from production system to product label• If Direct Marking is required, redesign product label• 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
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Step 5b – Evaluate, Select, and Implement GUDID Solution Choose Submission Method
* SaaS – Software as a Service
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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, dataentry, & 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 ValidationControlled VocabulariesFDA ESG Submission ACK Processing and Reporting
• On‐going Data Management (ease and capability)• “Future Proof”
ScalableInternational capabilities
• 21 CFR Part 11 Compliance (not relevant for FDA GUDID Web Interface)• Cost Effective
Implement Chosen Solution
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Survey Results – Your GUDID Solution Preferences
If yes, which of the following methods do you prefer?(224 responses)
Have you decided what method you will use to submit your UDI data to the GUDID?(274 responses)
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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
Note: Reed Tech provides ESG account setup and ESG submission as part of our service at no additional charge
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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
Note: Reed Tech provides SPL Test submissions using our ESG‐AS2 connection at no additional charge
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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, ERPLabeling System (label templates, dynamic data)Regulatory Systems
• If necessary, capture data from Label (e.g., “single use” icon)• Populate (55) GUDID Values into Records
Reed Tech GUDID Data Template is available to organize content
• 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 (http://go.reedtech.com/62-elements)
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 ControlLot/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 charactersDate 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 = LengthClinically Relevant Size Value = 25Clinically 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 ValuesPackaging and Kit Configurations
Data Validation is a Reed Tech core competency … we can help
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Step 8b – Normalize & Validate Source GUDID Data (available upon request)
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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Step 9 – Submit GUDID Data to FDA
“Go Live”• Submit Production device records• For Manual, Individual Record Entry:
Enter data via FDA GUDID Web InterfacePerform QC on Data Entry
• For Automated, Bulk Entry:Create fully‐valid SPL UDI submissions per FDA business rulesValidate SPL XML per FDA schema requirementsSubmit SPL UDIs to FDA via ESG
WebTrader – record‐by‐record manually driven processAS2 (Applicability Statement 2) – communication protocol for automated bulk transfer
SPL Validation and ESG Submission are Reed Tech core competencies … we can help
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Step 10 – Process ACK Messages
Applicable to SPL Submissions onlyMonitor and Collect FDA ACK messages• ACK 1 – FDA receipt confirmation• ACK 2 – CDRH receipt confirmation• ACK 3 – CDRH validation results
PassFail, explanatory error message provided
Report ACKsIndicate 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 labelsData Maintenance• Update/retire Device Labels and GUDID records as appropriate• Add Device Labels and GUDID records for new productsSystem Maintenance (for in‐house software only)• Update, Validate, Train, and Document system changesKnowledge 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 implementedPer 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 LSP GUDID 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• SaaS and Outsourced both available
Minimally intrusive Accepts data from your existing systems, initially and for subsequent, on‐going maintenance • Flexible data import options: XLS, XML, text file, manual entry
Save TimeReed Tech Life Science Portal can help save time during the data collection process• Data Transformations per Reed Tech Synonym Vocabulary• Data Aggregation• Data Collection Assistance available
Cost effective • Efficient, automated, bulk submissions • Save IT costs (e.g., hardware/software purchase, installation, validation, maintenance)
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Reed Tech UDI Solution Benefits (continued)
Flexible, Scalable and Future Architected GUDID solution• Accommodates additional custom/proprietary data fields beyond FDA
requirements• Easy expansion for future UDID submissions to global regulatory authorities
(EC, PMDA…)
Secure, Validated System• Secure, environmentally‐controlled data center
System meets all 21 CFR Part 11 technical compliance standards• Role‐based data management and approvals• Preparation, submission, and acknowledgement reporting• E‐signature submission approval
Gain an experienced corporate partnerOver 50 years of knowledge and expertise in data collection, content conversion and validation, submissions, lifecycle management, and excellent customer service
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Reed Tech UDI Resources
Available from ReedTech.com:GUDID Readiness Kithttp://go.reedtech.com/download‐free‐ebook‐udi‐readiness‐kit
Reed Tech GUDID Data Element Listhttp://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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Reed Tech Contact Information
Haley Lentz Account Executive, Life Sciences
Email: [email protected]
Phone: 1‐800‐772‐8368 or +1‐215‐441‐6438
Web: www.ReedTech.com
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Q&A
Please send questions
to “Staff” via webinar “Chat”
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Reference Material
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UDI ResourcesFDA
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 Resources (FDA Presentations: GUDID overview, account setup, etc.)• http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIden
tification/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 (G)UDID Data Elements
