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UDI - GUDID: What Medical Device Manufacturers need to know


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Class III medical device manufacturers must comply with FDA's UDI guidance by September 24, 2014. Class II manufacturers have until September 24, 2015. The guidance is quite complex and this is the third in a series of webinars from ReedTech on this subject. See for a downloadable transcript.

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UDI - GUDID: What Medical Device Manufacturers need to know

  1. 1. 1 1-800-772-8368 / +1-215-441-6438
  2. 2. 2 Agenda Reed Tech Company Profile FDA UDI / GUDID Update (“Homework”) Medical Device Manufacturers’ GUDID “To Do List” Class III Now Class II (and Class I) Soon Reed Tech GUDID Submission Solution Q&A
  3. 3. 3 Questions Please send questions during the session to “Staff” via webinar “Chat”
  4. 4. 4 Reed Tech Company Profile
  5. 5. 5 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 775 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 Headquarters Horsham, PA, USA Washington Operations Alexandria, VA, USA GS1 Solution Partner
  6. 6. 6 Reed Tech – Life Sciences Services Structured Product Labeling (SPL) Preparation, Submission, and Lifecycle Management • Service provider for over 775 life sciences companies  4 of the 5 largest pharma manufacturers in the world; large (200+ labels) to small (1 label)  Over 30,000 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  Highest volume submitter of SPLs (over 14,000)  Over 425 companies SPL
  7. 7. 7 Reed Tech – Life Sciences Services (continued) Structured Product Labeling (SPL) Preparation, Submission, and Lifecycle Management • Expertise in all CDER, CBER, and CVM Drug SPL types  Branded/Generic; Rx/OTC  SPL Original/PLR, R3/R4/R5, LCR/ER/SID/LL  Human Health, Biologics/Vaccines, Animal Health, etc. • Services for CDRH Medical Device UDI SPL (and IFU SPL)  Analysis, Data Aggregation, and Data Validation  SPL Build, Submission, and Change Management  Participated in FDA SPL-UDI pilot submission program (Oct 2012)  Currently participating in CDRH GUDID Load Testing SPL
  8. 8. 8 FDA UDI / GUDID Update “Homework” Please send questions during the session to “Staff” via webinar “Chat”
  9. 9. 9 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
  10. 10. 10 FDA UDI Compliance Timeline Class II Class I Compliance Timeline for UDI Implementation ILL Class II Class I 2 Class III GUDID data submitted to FDA and UDI on Label UDI Direct Marking 3 Class III 1) FDA UDI Final Rule published 2013-09-24 2) ILL = Implantable, Life-supporting, and Life-sustaining devices 3) Direct Marking required on multiple-use and reprocessed devices Final Rule 2014-09 2015-09 2016-09 2018-09 1 2020-09 ILL 2
  11. 11. 11 Key FDA UDI Documentation 2014-05-09 Data Elements & Issuing Agencies SPL Implementation Specification 2013-09-24 Draft System & Database 2014-02-13 Revision (SPL Folder name, FDA PT, etc.) 2014-04-14 Revision (MRI, DIN, Vocab) GUDID Guidance for Industry (GFI) 2013-11-21 XML Message Definition UDI Final Rule 2013-09-24 CFR Legal Basis Additional Support Website, Webinars, Video, Help Desk, (FAQ) 2014-06-11 Final GFI (phase 1/2) 2014-06-27 Final GFI (complete 2/2)
  12. 12. 12 UDI on Label vs. GUDID Submission Data Definitions •UDI = DI + PI(s) •GUDID Data = DI (not PI) + Device Attributes = 55 Submitted Fields Medical Device Manufacturer Label DataLabeling SystemUDI on Product & Pkg LabelGUDID Submission DataSource Data · MDM · ERP · Regulatory System · Database/File SystemsGUDID DataGUDIDGUDID data at FDA
  13. 13. 13 Recent UDI Regulatory News FDA Recent News •May 2014: “No new Data Elements for 24 Sep 2014” •“FDA GUDID Web Interface is designed for manufacturers with a small number of records. SPL is recommended for larger record volumes” •“Class III Labelers can submit their Class II and I records now” •CDRH performing interim manual quality checks on submissions •Manufacturers that finished GUDID Pre-Production SPL Test Scenarios are now granted permission to create their GUDID Production Accounts FDA Final Rule: •Request time for Class III Extension expired June 23, 2014 •Request to Continue Labeler Code due by Sep 24, 2014 Health Canada •2 July 2014: Announced UDI plan to conform to IMDRF Guidelines. IMDRF dataset adds and deletes some data elements relative to the FDA data set
  14. 14. 14 Medical Device Manufacturers’ GUDID “To Do List” Class III Now Class II (and Class I) Soon Please send questions during the session to “Staff” via webinar “Chat”
  15. 15. 15 Have you decided what method you will use to submit your UDI data to the GUDID? (316 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? (324 responses) What device classes does your organization manufacture (select all that apply)? (324 responses)
  16. 16. 16 Class II (and Class I) Benefits Early UDI Adoption Customer Requests/Visibility •Many hospitals and healthcare providers have started their UDI implementation process and are requesting their medical device suppliers to provide UDI information •Manufacturers who adopt UDI early will have the benefit of early visibility in the GUDID to buyers of their products Smooth Your Workload •High volume of Class II (and Class I) products will require significant effort and time to collect, organize, and clean data – start early Avoid Potential FDA Delays •According to the FDA FURLS database, there are over 20 times more Class II products than Class III. Early adoption can mitigate the potential risks of FDA submission delays International Compliance •Early FDA UDI adopters will be in better position to meet future international deadlines
  17. 17. 17 UDI / GUDID To Do List – Step 1 Analyze and Plan UDI Implementation •Review UDI Final Rule, Specs, Exceptions, Direct Marking, Timing, etc. UDI Final Rule Final GUDID Guidance for Industry GUDID Data Elements Reference Table SPL Implementation Files •Evaluate your “data situation” (data location, gaps, owners, formats, etc.) •Select Issuing Agency (GS1, HIBCC, or ICCBBA) for Product Identification (Primary DI, etc.) UDI Formats by FDA-Accredited Issuing Agency •Select AIDC Technology (1D, 2D, etc.) for UDI Presentation on Label
  18. 18. 18 UDI / GUDID To Do List – Step 2 Update Systems •Production System, e.g., PLM, MDM, ERP •Labeling System (templates, content)
  19. 19. 19 UDI / GUDID To Do List – Step 3 Collect, Normalize, and Validate source GUDID data •Collect data from multiple sources; generate values as required (Reed Tech GUDID Data Template available) •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) •“Problematic” Data Elements Labeler DUNS Number(s) Device Identifiers GMDN or FDA Preferred Term Values Packaging Configuration
  20. 20. 20 GUDID Data 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
  21. 21. 21 GUDID Data Record (available upon request from Haley) 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)
  22. 22. 22 UDI / GUDID To Do List – Step 4 Choose Submission Method * SaaS – Software as a Service
  23. 23. 23 GUDID Data Submission Methods 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 •“No” software cost •Your admin, data entry, & QA 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 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
  24. 24. 24 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 responsible 3rd Party organization is not directly responsible •Consider Solution Capabilities and Expertise SPL Data Validation Controlled Vocabularies FDA ESG Submission ACK Processing and Reporting Maintenance For Class III manufacturers, probably too late to implement internal software solution
  25. 25. 25 UDI / GUDID To Do List – Step 5a GUDID Pre-Production Account Set Up Process •Request a Pre-Production (Test) GUDID Account Request Form from the FDA
  26. 26. 26 UDI / GUDID To Do List – Step 5b GUDID Pre-Production Account Set Up Process •Complete the GUDID Account Request Form (Identify Labeler DUNS Numbers / Users) Attachment to email from the FDA (top half of page 1; 3 pages total)
  27. 27. 27 UDI / GUDID To Do List – Step 5c 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 Note: Reed Tech provides ESG account setup and ESG submission as part of our service
  28. 28. 28 UDI / GUDID To Do List – Step 5d ESG Account Testing Process (if using SPL Submissions) •Complete 4 Test Scenarios – SPL submission into GUDID Note: Reed Tech provides SPL Test submissions as part of our service
  29. 29. 29 UDI / GUDID To Do List – Step 6 GUDID Production Account Set Up Process •Request a Production GUDID Account •Use same Application form as the GUDID Pre-Production Account Request Go Live •Submit existing device records •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 rules Submit SPL UDIs to FDA via ESG (WebTrader, AS2) On-going Maintenance •Submit changes/revisions •Submit new device records
  30. 30. 30 Reed Tech GUDID SPL Submission Solution (SaaS or Outsourced) Please send questions during the session to “Staff” via webinar “Chat”
  31. 31. 31 Reed Tech GUDID SPL Solution (SaaS or Outsourced) Medical Device ManufacturerMfr (SaaS) or Reed Tech (Outsourced) processes initial and maintenance FDA UDI submissionsReed Tech Life Sciences Portal - UDI System“The Last Mile” ESGFDA(FDA(or EU, PMDA, …) GUDIDUDI DatabaseUDI Data ~~~~~ ~~~~~ Custom FieldsSPL-UDIFilesControlled VocabProcess ACKSubmit SPLEdit/ MaintainBuild, Validate, Approve SPLPrepare DataTransform, Merge, Load, Validate & Review DataESGPLM, MDM, ERP/MES, RA, Labeling, ... ReportsData CollectionImport Bulk Files(XLS, XML, GDSN, TXT) Reports, UpdatesTerminologyIndustry StandardsIndustry Standards
  32. 32. 32 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 •Multiple data import options: XLS, XML, GDSN, TXT Save Time •Data Transformations available per Reed Tech Synonym Vocabulary •Data Aggregation Cost effective •Efficient, automated, bulk submissions •Save IT costs (e.g., hardware/software purchase, installation, validation, maintenance)
  33. 33. 33 Reed Tech UDI Solution Benefits (continued) Flexible UDI Solution •SaaS and Outsourced both available •Accommodates additional custom/proprietary data fields beyond FDA requirements •Easy expansion for future UDI submissions to other global regulatory authorities (Health Canada, EC, PMDA …) •FDA GUDID Web Interface will have limited value in meeting non-U.S. GUDID mandates. Compliant System •Secure •Validated •21 CFR Part 11 Compliant Role-based data management and approvals Reporting (audit trail, version history) Only 55 days until FDA Class III submissions are due! Reed Tech Solution can easily meet this deadline
  34. 34. 34 Reed Tech UDI Resources Available from Reed Tech GUDID Data Element List Reed Tech GUDID Record Template Available upon request Multiple Options To Weigh For Moving A UDI Into FDA’s Database “The Gray Sheet” 6 January 2014 UDI Training Course (in collaboration with Lernia Training Solutions) Sample GUDID Account Request Form Available upon request
  35. 35. 35 Reed Tech Contact Information Haley Lentz Account Executive, Life Sciences Email: Phone: 1-800-772-8368 or +1-215-441-6438 Web:
  36. 36. 36 Q&A Please send questions to “Staff” via webinar “Chat”
  37. 37. 37 Reference Material
  38. 38. 38 UDI Resources FDA UDI “Home Page” •UDI Rule, GUID Guidance, Compliance Dates, Resources • UDI Help Desk • GUDID Information •Basics, Guidance, Account Request, GUDID Web Interface, HL7 SPL, GUDID Status • GUDID Web Interface (Login) • CDRH Learn (FDA Presentations: GUDID overview, account setup, etc.) • IMDRF – EC Medical Devices –
  39. 39. 39 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; 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; 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); 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.