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Unique Device Identification UDI Requirements and Timelines

Unique Device Identification UDI Requirements and Timelines



http://MedicalDevicesGroup.net Reed Technology, in collaboration with the Medical Devices Group, present information regarding the FDA's Unique Device Identifier (UDI) and discuss strategies to ...

http://MedicalDevicesGroup.net Reed Technology, in collaboration with the Medical Devices Group, present information regarding the FDA's Unique Device Identifier (UDI) and discuss strategies to implement your UDI submissions solution.



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    Unique Device Identification UDI Requirements and Timelines Unique Device Identification UDI Requirements and Timelines Presentation Transcript

    • www.ReedTech.com +1‐800‐772‐8368
    • Agenda Reed Tech Company Profile FDA Unique Device Identifier (UDI) Requirements Medical Device Manufacturers’ GUDID Challenges Reed Tech GUDID Submission Solution Q&A www.ReedTech.com 2
    • Questions Please send questions  during the session via  webinar “Chat” www.ReedTech.com 3
    • Reed Tech Company Profile www.ReedTech.com 4
    • Reed Tech Profile A recognized leader in providing solutions  for content and lifecycle management 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 Certified to ISO 9002  in 1998 Upgraded to ISO  9001:2008 in 2008 www.ReedTech.com Philadelphia Headquarters Horsham, PA, USA Washington Operations Alexandria, VA, USA HL7 Organization  Member since 2005 5
    • Reed Tech – Life Sciences Services Structured Product Labeling (SPL) Preparation, Submission, and Lifecycle Management • Service provider for over 700 life sciences companies 6 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 2005 Most experienced SPL service provider in the industry • FDA Electronic Submissions Gateway (ESG) service Highest volume submitter of SPLs (over 13,000)  Over 375 companies www.ReedTech.com 6 SPL
    • 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) www.ReedTech.com 7 SPL
    • FDA UDI Requirements for  Medical Devices Please send questions during the session to “Staff” via webinar “Chat” www.ReedTech.com 8
    • 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 www.ReedTech.com 9
    • UDI Implementation Timeline Key FDA Actions 2013-09-24 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 www.ReedTech.com 10
    • UDI Regulation Overview Labeling 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… • If AIDC is not visible, add disclosure Date Format YYYY-MM-DD (2013-10-29) UDI on “Device” Software Direct Part Marking (DPM) Permanently mark UDI on device itself Multiple use and reprocessed devices FDA Global UDI Database (GUDID) (“Good-I-D”) Submit DI and device metadata Public access, global model www.ReedTech.com GUDID 11
    • 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 label Convenience Kits: UDI required on kit, UDI not required on components Combination Product: UDI required on product, UDI not required on  components (special NDC cases) Inventory Exception: +3 years after Class compliance date Class III Extension: +1 year, if request is approved  Manufacturer determines UDI update: based on new version/model  number Medical Device Reporting, Facility Annual Report: must include UDI More items in Appendix www.ReedTech.com 12
    • Medical Device Manufacturers’  GUDID Submission Challenges Please send questions during the session to “Staff” via webinar “Chat” www.ReedTech.com 13
    • UDI Implementation Challenges Product Design Label, DPM Financial Funding, Budget Manufacturing Revised Label, DPM UDI Governance Analysis, Planning, Roadmap Production Control MDM, Inventory, Supply Chain Marketing Publish, Order Mgmt All data may not be in accessible electronic format Regulatory Collect and Submit Data to FDA www.ReedTech.com Data is most likely in disparate systems 14
    • Results of Attendees Survey Q1 - Estimate the total number of product SKUs you need to submit to the FDA for all classes. (309 responses) Uncertain or Not Applicable > 100,000 50,001 – 100,000 10,001 – 50,000 1,001 – 10,000 101 – 1,000 < 100 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) 28% 2% Uncertain or Not Applicable 2% Identification, etc. completed 3% 3% Identification, etc. underway 12% 9% Planning started 11% 20% 40% 26% Not started 41% 0% 26% 60% 37% 0% 20% 40% Q2 - What device classes does your organization manufacture (select all that apply)? (474 responses) Q4 - What method would you prefer to use to submit your UDI data to the FDA? (307 responses) Uncertain or Not Applicable Class I Class II Class III Uncertain or Not Applicable Use the FDA GUDID web tool Use a service provider Use purchased software Use internally developed tool 21% 40% 64% 29% 0% www.ReedTech.com 20% 40% 60% 80% 65% 14% 4% 4% 12% 0% 15 20% 40% 60% 80%
    • GUDID Data Collection and Submission Steps www.ReedTech.com 16
    • GUDID Data Submission Plans 1. Evaluate your “data situation” (location, gaps, owners, formats, etc.) 2. Determine your best GUDID data submission method/tool 3. 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 Tool 5. 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 www.ReedTech.com 17
    • GUDID Data Record GUDID Data Record Approximately 55 Fields 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) … Reference: Appendix B, Draft GUDID Guidance for Industry www.ReedTech.com 18
    • GUDID Data Submission Options Submission Method Description/Comments FDA GUDID Tool • You (or third party) enter data directly into the FDA GUDID • Transcription error concern • Low volume Outsourced Service • External provider accepts your data, builds and submits SPLs to FDA via the ESG on your behalf Technology Cost • “No” tool cost SaaS • Use external tool to collect data, (Software as build and submit SPLs to FDA via a Service) the ESG UDI Software Utility Operations Cost • Admin, data entry & QA labor (yours or third party) • “No” tool cost • “No” Admin & operations labor • Service cost • “Rent” tool • Admin & operations labor • Buy / build / upgrade an internal tool • “Own” tool (buy/build/upgrade, (ERP, PLM, MDM, Labeling or other) • Admin & install, validate, to collect data and build SPLs operations labor train, maintain) • Submit SPLs to FDA via the ESG • ESG account (AS2) (AS2) www.ReedTech.com 19
    • Reed Tech GUDID SPL Submission Solution  (SaaS or Outsourced) Please send questions during the session to “Staff” via webinar “Chat” www.ReedTech.com 20
    • Reed Tech GUDID SPL Solution (SaaS or Outsourced) www.ReedTech.com 21
    • Reed Tech UDI Solution Benefits Simple – minimal change to your current processes Least intrusive – supply data from your existing systems, initially and  for subsequent, on‐going maintenance Cost 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 www.ReedTech.com 22
    • Q&A Please send questions to “Staff” via webinar “Chat” www.ReedTech.com 23
    • Reed Tech Contact Information Gary Saner Mark Bayer Sr. Manager, Information Solutions – Life Sciences 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 24
    • 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 stockpile Stand‐alone Software: UDI required, downloads exempt from AIDC Class I GMP Exception: UDI not required Class I Exception: No PI required Class I Retail Exception: UPC can be UDI … www.ReedTech.com 25