12 Steps for Medical Device UDI Submissions to the FDA GUDID
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UDI regulations kick in for Implantables and Class II devices in 2015. Reed Tech subject matter expert Gary Saner is my go-to on this subject. He covered: • Requirements of a GUDID submission system • Process steps in selecting/launching a GUDID system and making submissions • Data Fields – including those that are problematic • Data Cleaning, Harmonization, and Validation tips • Update on FDA’s changing GUDID guidance, e.g., convenience kits and implants • Notes in setting up a FDA GUDID account RELEVANT FOR: • UDI Team Leaders/Members • Regulatory Directors/Managers/Staff • Manufacturing, Operations, and Supply Chain Logistics Personnel • UDI IT Support Personnel • Compliance Officers • Distributors with UDI Submission Responsibilities Video at http://medgroup.biz/UDI-in-2015
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12 Steps for Medical Device UDI Submissions to the FDA GUDID
- 3. www.ReedTech.com 3 Questions Please send questions during the session to “Staff” via webinar “Chat”
- 6. www.ReedTech.com 6 Reed Tech – Pharma Services SPL Preparation, Submission, and Lifecycle Management for Drug Establishment Registration and Drug Product Labeling/Listing • Service provider for over 800 pharma companies 4 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 2005 Most experienced SPL service provider in the industry • Global customers Over 70 companies in over 25 countries outside the U.S. • FDA Electronic Submissions Gateway (ESG) service ESG WebTrader and AS2 connections Highest volume submitter of pharma SPLs (over 15,000) Over 450 companies • Experts in CDER, CBER, and CVM Drug SPLs Data Transformation/Validation SPL Build, ESG Submission, and FDA Acknowledgement SPL Lifecycle Management SPL
- 7. www.ReedTech.com 7 Reed Tech – Medical Device Services SPL Preparation, Submission, and Lifecycle Management for Medical 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 SPL Analysis, Data Aggregation/Transformation/Validation SPL Build, ESG Submission, and FDA Acknowledgement GUDID Data Life Cycle Management (SaaS and Outsourced model) SPL * Calculations based upon FDA statistics presented at Clarion UDI Conference, Baltimore, 28 Oct 2014
- 8. www.ReedTech.com 8 Reed Tech – Medical Device Services (continued) • FDA Electronic Submissions Gateway (ESG) service Participated in FDA Pilot Submissions Program in 2014 to assist agency in high volume GUDID ESG load testing ESG AS2 connection for automated, bulk SPL submissions FDA Acknowledgment reporting GUDID Publication status (unpublished, grace period, published, off market) • Global Roadmap Support customers’ needs for international UDID submissions as mandated Reed Tech System is designed to readily accommodate: Expanded data set of IMDRF and regional UDID attributes Building UDI submissions per regional specifications Submitting to international regulatory agencies
- 9. www.ReedTech.com 9 FDA UDI / GUDID Refresher Please send questions during the session to “Staff” via webinar “Chat”
- 10. www.ReedTech.com 10 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 (2013-09-29) FDA UDI Regulation Overview FDA Global UDI Database (GUDID) Submit DI and device attributes Public access, global model GUDID Reporting – include UDI as available
- 11. www.ReedTech.com 11 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
- 13. www.ReedTech.com 13 Recent UDI Regulatory News FDA 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
- 14. www.ReedTech.com 14 12 Steps for Accurate GUDID Submissions Please send questions during the session to “Staff” via webinar “Chat”
- 15. www.ReedTech.com 15 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 Status How 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)
- 16. www.ReedTech.com 16 12 Steps Summary 1. Create UDI Governance Team 2. Research/Identify FDA UDI Requirements for Your Products 3. Evaluate Your Situation 4. Define and Implement UDI Labeling Plan 5. Evaluate, Select, and Implement GUDID Solution 6. Create FDA Accounts (GUDID, ESG) 7. Collect Source GUDID Data 8. Normalize and Validate Source GUDID Data 9. Submit GUDID Data to FDA 10. Process ACK Messages 11. Initiate & Maintain Data and System 12. International Readiness pUDI Prep pGUDID Prep Production
- 17. www.ReedTech.com 17 Step 1 – Create UDI Governance Team UDI Governance Analysis, Planning, Roadmap Product Design Label, DM Mfg Label, DM Production Control MDM, Inventory, Supply ChainRegulatory 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
- 18. www.ReedTech.com 18 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
- 19. www.ReedTech.com 19 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
- 20. www.ReedTech.com 20 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) 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.)
- 22. www.ReedTech.com 22 Step 5b – Evaluate, Select, and Implement GUDID Solution Choose Submission Method * SaaS – Software as a Service
- 23. www.ReedTech.com 23 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 • 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
- 24. www.ReedTech.com 24 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
- 25. www.ReedTech.com 25 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)
- 26. www.ReedTech.com 26 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/Glob alUDIDatabaseGUDID/default.htm#account
- 27. www.ReedTech.com 27 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)
- 28. www.ReedTech.com 28 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
- 29. www.ReedTech.com 29 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 http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/Gl obalUDIDatabaseGUDID/UCM376009.zip Note: Reed Tech provides SPL Test submissions using our ESG‐AS2 connection at no additional charge
- 30. www.ReedTech.com 30 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
- 31. www.ReedTech.com 31 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 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
- 32. www.ReedTech.com 32 Step 7b – Collect Source GUDID Data Reference: FDA “GUDID GFI” Jun 27 2014GUDID Data (directly) GUDID Data (needs coding)
- 33. www.ReedTech.com 33 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 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 # Labeler Labeler DUNS # Labeler Name* Labeler Address* Contact Phone Contact Email 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* Production Control Lot/Batch (Y/N) Serial # (Y/N) Mfg Date (Y/N) Expiration Date (Y/N) Donation Id # (Y/N) 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 * Populated by FDA GUDID System
- 34. www.ReedTech.com 34 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 Data Validation is a Reed Tech core competency … we can help
- 35. www.ReedTech.com 35 Step 8b – Normalize & Validate Source GUDID Data (available upon request) 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)
- 36. www.ReedTech.com 36 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 SPL Validation and ESG Submission are Reed Tech core competencies … we can help
- 37. www.ReedTech.com 37 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)
- 38. www.ReedTech.com 38 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)
- 39. www.ReedTech.com 39 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)
- 40. www.ReedTech.com 40 Reed Tech LSP GUDID Submission Solution (SaaS or Outsourced) Please send questions during the session to “Staff” via webinar “Chat”
- 42. www.ReedTech.com 42 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 Time Reed 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)
- 43. www.ReedTech.com 43 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 partner Over 50 years of knowledge and expertise in data collection, content conversion and validation, submissions, lifecycle management, and excellent customer service
- 44. www.ReedTech.com 44 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 2014 http://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
- 45. www.ReedTech.com 45 Reed Tech Contact Information Haley Lentz Account Executive, Life Sciences Email: hlentz@reedtech.com Phone: 1‐800‐772‐8368 or +1‐215‐441‐6438 Web: www.ReedTech.com
- 46. www.ReedTech.com 46 Q&A Please send questions to “Staff” via webinar “Chat”
- 48. www.ReedTech.com 48 UDI Resources FDA 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
- 49. www.ReedTech.com 49 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; 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.org 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); 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 Agency XML Extensible Markup Language – markup language defining a set of rules for document encoding in both human and machine readable language.