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2 Agenda Reed Tech Company Profile FDA Unique Device Identifier (UDI) Requirements Medical Device Manufacturers GUDID Challenges Reed Tech GUDID Submission Solution Q&A 2

3 Questions Please send questions during the session via webinar Chat 3

4 Reed Tech Company Profile 4

5 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 Philadelphia Headquarters Horsham, PA, USA Washington Operations Alexandria, VA, USA Certified to ISO 9002 in 1998 Upgraded to ISO 9001:2008 in 2008 HL7 Organization Member since

6 Reed Tech Life Sciences Services Structured Product Labeling (SPL) Preparation, Submission, and Lifecycle Management SPL 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 6

7 Reed Tech Life Sciences Services (continued) Structured Product Labeling (SPL) Preparation, Submission, and Lifecycle Management SPL 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) 7

8 FDA UDI Requirements for Medical Devices Please send questions during the session to Staff via webinar Chat 8

9 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 9

10 UDI Implementation Timeline Key FDA Actions FDA released UDI Final Rule and Draft GUDID Guidance for Industry (database definition) ?? Awaiting GUDID SPL Implementation Specification (SPL XML message definition). Delay is due to federal government shutdown Comment period for Draft GUDID Guidance for Industry will end. Final GFI TBD. Reference: FDA UDI website 10

11 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 ( ) 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 GUDID 11

12 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 12

13 Medical Device Manufacturers GUDID Submission Challenges Please send questions during the session to Staff via webinar Chat 13

14 UDI Implementation Challenges Product Design Label, DPM Financial Funding, Budget Manufacturing Revised Label, DPM Marketing Publish, Order Mgmt UDI Governance Analysis, Planning, Roadmap Production Control MDM, Inventory, Supply Chain Data is most likely in disparate systems Regulatory Collect and Submit Data to FDA All data may not be in accessible electronic format 14

15 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, ,000 10,001 50,000 1,001 10, ,000 < 100 2% 2% 3% 12% 11% 28% 41% 0% 20% 40% 60% 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) Uncertain or Not Applicable Identification, etc. completed Identification, etc. underway Planning started Not started 3% 9% 26% 26% 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 21% 29% 40% 64% 0% 20% 40% 60% 80% Uncertain or Not Applicable Use the FDA GUDID web tool Use a service provider Use purchased software Use internally developed tool 4% 4% 14% 12% 65% 0% 20% 40% 60% 80% 15

16 GUDID Data Collection and Submission Steps 16

17 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 17

18 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 18

19 GUDID Data Submission Options Submission Method Description/Comments Technology Cost Operations Cost FDA GUDID Tool You (or third party) enter data directly into the FDA GUDID Transcription error concern Low volume No tool cost Admin, data entry & QA labor (yours or third party) Outsourced Service External provider accepts your data, builds and submits SPLs to FDA via the ESG on your behalf No tool cost No Admin & operations labor Service cost SaaS (Software as a Service) Use external tool to collect data, build and submit SPLs to FDA via the ESG Rent tool Admin& operations labor UDI Software Utility Buy / build / upgrade an internal tool (ERP, PLM, MDM, Labeling or other) to collect data and build SPLs Submit SPLs to FDA via the ESG (AS2) Own tool (buy/build/upgrade, install, validate, train, maintain) ESG account (AS2) Admin& operations labor 19

20 Reed Tech GUDID SPL Submission Solution (SaaS or Outsourced) Please send questions during the session to Staff via webinar Chat 20

21 Reed Tech GUDID SPL Solution (SaaS or Outsourced) 21

22 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 22

23 Q&A Please send questions to Staff via webinar Chat 23

24 Reed Tech Contact Information Gary Saner Sr. Manager, Information Solutions Life Sciences Mark Bayer VP, Business Development Haley Lentz Account Executive, Life Sciences Web: Phone:

25 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 , 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 25