Help! How Can I Complete UDI by September?

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1 Event: LinkedIn - Medical Devices Group Medical Device UDI Webinar Series Help! How Can I Complete UDI by September? Gary Saner Sr. Manager, Information Solutions - Life Sciences gsaner@reedtech.com

2 Agenda Recap FDA s UDI Compliance Regulation How to Complete Your UDI Compliance by September 2016 Review Reed Tech s Solution Q&A 2

3 FDA UDI Regulation Overview FDA Final Rule 3

FDA UDI Regulation Overview Label UDI (Device Id + Production

and Automatic Id and Data Capture (AIDC) technology

2013-09-24) (except AIDC date must use Issuing Agency date

use and reprocessed devices FDA Global UDI Database (GUDID)

portal, AccessGUDID, to FDA GUDID) Reporting UDI in Annual

4 FDA UDI Regulation Overview Label UDI (Device Id + Production Id) on Device Label & Pkg UDI in human-readable plain-text and Automatic Id and Data Capture (AIDC) technology (e.g., 1D/2D barcode, RFID) Date Format YYYY-MM-DD (e.g., ) (except AIDC date must use Issuing Agency date format) Direct Marking (DM) Permanently mark UDI on multiple use and reprocessed devices FDA Global UDI Database (GUDID) Submit DI and device attributes to GUDID (NLM provides public portal, AccessGUDID, to FDA GUDID) Reporting UDI in Annual Reports, DHR, Complaints, MDR, Recalls, Service, Tracking, Post Marketing Surveillance 4

Submission = DI (not PI) + Device Attributes = 55 Fields

5 UDI Impact on Industry Labeling System = all existing elements + UDI (DI + PIs) in HRI & AIDC forms GUDID Submission = DI (not PI) + Device Attributes = 55 Fields Documentation = supporting DHF, QMS, SOPs, Validation, Records, etc. 5

6 FDA UDI Compliance Timeline Final Rule Data in GUDID & UDI on Label Class III I/LS/LS 2 Class II Contact Lens Class I UDI Direct Marking 3 All LS/LS 2 Class III Class II Class I 1) FDA UDI Final Rule published ) I/LS/LS = Implantable, Life-supporting, and Life-sustaining devices 3) Direct Marking (DM) required on multiple-use and reprocessed devices Only 4 months, 76 working days, until FDA Class II submissions are due! 6

7 5 Steps of GUDID Implementation 5. Maintenance 4. GUDID Data Submission 3. GUDID Data Prep 2. GUDID System Prep 1. UDI Prep 7

8 UDI & GUDID Implementation Step 1 1. UDI Prep A. Create UDI Governance Team B. Identify FDA UDI Requirements for Your Products C. Evaluate Your Situation D. Prepare UDI Environment 8

9 1A Create UDI Governance Team Sales & Marketing Catalog, Publishing, Order Mgmt Quality SOPs, Reporting, Records, Training Product Design ID, Label & DM Design UDI Governance Analysis, Planning, Funding, Budget Regulatory Compliance, Data Submission to GUDID Mfg Label, DM & Bar Code Systems, Verification Operations MDM, ERP, Inventory, Supply Chain 9

10 1B Identify FDA UDI Requirements for Your Products Learn the Basics UDI Home, UDI Resources, CDRH Learn UDI System Research FDA UDI Final Rule & Guidance Relevant to Your Products UDI System Small Entity Compliance Guide UDI System Final Rule GUDID Guidance for Industry GUDID Data Elements Reference Table SPL Implementation Files Identify Your Device Classes (I, II, III, I/LS/LS) / Product Codes Compliance Dates Exceptions (numerous) Extensions - Intraocular Lens (2015), Non-sterilized Implants (Labels 2016), Contact Lens (2017) Refer to Industry Associations, Consultants, and Vendors 10

11 1C Evaluate Your Situation Evaluate Your Data Situation Data location, gaps, owners, formats, etc. Evaluate Internal Standards Product Identification / Batch / Serialization / Dates Issuing Agency (GS1, HIBCC, or ICCBBA) for Product Identification UDI Formats by FDA-Accredited Issuing Agency Evaluate Processes Workflow Compliance Documentation Training Evaluate Systems Existing MDM, Labeling System, ERP, etc. Existing AIDC Technology (1D, 2D, etc.) for UDI Presentation on Label Consider Gap Analysis by external party 11

12 1D Prepare UDI Environment Update Product ID Standard & Procedures Select and implement Issuing Agency (GS1, HIBCC, or ICCBBA) standard Assign Device Identifiers to Products (Primary, Secondary, Unit of Use, Direct Marking, Package Levels) Define Production IDs for Batch / Serialization / Dates (ensure uniqueness) Update Process and Compliance Procedures Establish Data Management Procedures Create Documentation (DHF, SOPs, Work Instructions, Reports, etc.) Perform System Validation and Training 12

13 1D Prepare UDI Environment Revise Labeling System Product & Package Label Templates - Add Human Readable UDI presentation - Implement AIDC UDI presentation (1D, 2D, RFI, etc.) - Revise Date format (YYYY-MM-DD) on templates (add day) Ensure dynamic data flows from production system to product label Verify UDI content and AIDC barcode quality (Barcode Verifier Reader) If Direct Marking is required, implement permanent product label Revise Production Systems Product Design: PLM Manufacturing: Label Printing System, Label Inspection System Operations: MDM, ERP, Supply Chain (mfg, storage, shipping, end user) Regulatory & Quality: Compliance, Validation, Documentation UDI Prep Time Varies: Could be 4 to 18 months Consider experienced UDI assistance; No time for major system changes 13

14 UDI & GUDID Implementation Step 2 2. GUDID System Prep A. Evaluate, Select, and Implement GUDID Solution B. Create FDA GUDID Accounts (all Labelers) C. Create FDA ESG Accounts (only SPL submissions) 14

15 2A Evaluate, Select & Implement GUDID Solution GUDID Web Interface manual web-form entry of single records Structured Product Labeling (SPL) electronic XML file entry via Electronic Submissions Gateway (ESG) 15

16 2A GUDID Submission Methods 16

17 2A GUDID Submission Method Comparison Submission Method Description/Comments Technology Cost Operations Cost FDA GUDID Web Interface Manually enter data directly into the GUDID web form, one record at a time Best suited for low volume Transcription error concern No reuse for international agencies 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 ESG Low to high volume submissions Rent software Your Admin labor Outsourced Service External provider accepts your data, builds and submits SPLs to FDA via ESG on your behalf Rent software No internal Operations labor Service cost On-Premises Installed Software Buy / build / upgrade internal software (PLM, MDM, ERP, Labeling or other) to collect data, build and submit SPLs to FDA via ESG High volume submissions Own software (buy/build/upgrade, install, validate, train, maintain) ESG account (AS2) Your Admin & Operations labor 17

18 2A GUDID Submission Selection & Implementation Provider Expertise and Experience Characteristics A B C System Practical Processing of Low/Medium/High Volumes Robust Current Data Validation, Controlled Vocabularies Data Management (roles, navigation, ease of use) If SPL: FDA ESG Account and GUDID SPL Testing SPL: FDA ACK Processing and Reporting SPL: 21 CFR Part 11 Compliant (required for SPL systems) Implementation Startup Time/Effort Impact/Connectivity to Existing Systems Future Proof Scalable for Additional Records International UDID Roadmap Support SME Knowledge, Access, Timing Cost Effective Implement Chosen Solution: Purchase Startup Validate Train 18

19 2B/C Create FDA Accounts Refer to FDA UDI Home Page Create FDA GUDID Account Submit Request Identifying Responsible Company, Labeler Companies, Users, etc. FDA Provides Credentials Create FDA Electronic Submission Gateway (ESG) Account (for electronic SPL submissions) Setup & Test Pre-production Submissions Setup Production Account Look for a vendor supporting GUDID & ESG Account setups 19

20 UDI & GUDID Implementation Step 3 3. GUDID Data Prep A. Collect Source GUDID Data B. Normalize and Validate Source GUDID Data 20

21 3A Collect Source GUDID Data 21

22 3A Collect Source GUDID Data Collect Data From Multiple Sources: Production Systems, e.g., PLM, MDM, ERP Regulatory System Labeling System (label templates, label records) External Organizations (D&B, GMDN, FDA, GS1 / HIBCC / ICCBBA) Populate (55) GUDID Values Into Records Use GUDID Data Template to Organize and Collect Content Merge Partial Records From Multiple Data Sources If Desired, Collect Additional Data Fields Your Internal Purposes (id, ownership, tracking status, date, etc.) Future UDI Submissions to International Regulatory Authorities UDI Data ~~~~~ ~~~~~ ~~~~~ Look for a vendor supporting GUDID Data Collection 22

23 3A FDA GUDID Data Attributes (62 total) 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 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 55 Attributes Submitted by Labeler (some can have multiple values) 7 Additional Attributes Populated by FDA GUDID System (*) 23

24 3A GUIDID Data Template GUDID Data Template Working Repository Comprehensive List of Attributes Identifies Reqd, Conditional and Optional Fields Quick Reference Guidance 24

25 3A Data Collection Issues Data Volume 1,000 device records have 55,000 fields (some universal, but most are unique) Data is most likely in Disparate Locations Systems: MDM, ERP, Labeling, Regulatory, etc. Local Computers: uncontrolled spreadsheet or attachment Identifying Data Owners (may have left the company) Data has Varying Formats Data may not exist in Digital Format Label Template has graphical Single-Use symbol, but data is not stored digitally Problematic Data Fields Labeler DUNS Numbers GMDN or FDA Preferred Term Values Device Identifier Assignment (Base Product Primary DI, Secondary DI, DM DI, UoU DI, Pkg Level DIs) Packaging & Kit Configurations 25 Databases / File Systems

26 3B Normalize & Validate Source GUDID Data 26

27 3B Normalize & Validate Source GUDID Data Normalize Data to FDA GUDID Specs Apply FDA Business Rules - GS1 GTINs must be 14 numeric characters - Date Format must be YYYY-MM-DD Utilize Controlled Vocabularies (List of Values, LoV) - cm for Size Unit of Measure (centimeter) - Cel for Temperature (C) Some advanced GUDID Submission Systems provide automatic transformation to normalize data For Grouped Data, all fields in the set must be populated - Clinically Relevant Size Type = Length - Clinically Relevant Size Value = 25 - Clinically Relevant Size Unit = cm For Dependent Data, corresponding fields must be populated - If Require Sterilization prior to use? is Yes, then Sterilization Method must be populated Validate all Content The key to accuracy for your SPL submissions to the FDA 27

28 3B Data Normalization & Validation Issues GMDN Code is Obsolete GMDN codes may become inactive; typically replaced by more granular codes Check GMDN Terminology to confirm Code is current FDA, one GMDN code is usually sufficient. FDA receives GDMN updates twice a month, 1st and 15th of the month; FDA tries to load within 72 hours to one week. List of Values Must use exact value in FDA LoV, e.g., MRI Safe must be MR Safe DI Values UDI Data ~~~~~ ~~~~~ ~~~~~ For GS1: Enter GTIN-14 (14 digit numeric value) - Pad leading 0 s to GTIN-12 and GTIN-13 - Omit the leading "(01)" Application Indicator; include the trailing Check Digit. For HIBCC: Enter HIBC (6-23 character alphanumeric value) - Omit leading "*+" and omit trailing Check Character and "*". Barcode data HRI data GUDID data 28

29 3B Data Lessons (1/2) Item Errors to Avoid Comment 1 Incorrect data value (transposed, typo, etc.) Perform quality check 2 Incorrect data or date format Check specification 3 Value not in FDA LoV Check value matches exactly 4 PI included in GUDID submission Submit only DI, not PI 5 GTIN (01) or HIBC *, +, or Check Char included in DI 29 Submit only GUDID version of DI value 6 Invalid check digit for GTIN DI Run algorithm on final value 7 Incorrect DM DI or Pkg DI for the Base Product DI Check DIs are for same device 8 Invalid Labeler DUNS Number Check DUNS # matches DUNS # in Account Application 9 Invalid FDA Listing Number Check FDA documentation 10 Invalid GMDN Code Verify GMDN Code is active

30 3B Data Lessons (2/2) Item Errors to Avoid Comment 11 Invalid Donation Id Number (DIN) Flag True only for ICCBBA devices 12 Invalid Pkg Configuration (count, UoU DI, Pkg DI) Don t report 1-in-1 Pkg, 13 Prefix text included in Model/Version field, e.g., Model, Version, V, ver, Release 14 Device Description field is empty Clinically Relevant Size Description field used instead of dedicated fields for Type, Value, Unit Optional fields are empty, e.g., Catalog Number, Storage & Handling, Clinically Relevant Size Submit just identifier, e.g., ABC-24, 2.3 Recommend approved/ cleared Indications for Use Preference is to have structured, sortable data Include data if on label ( Optional doesn't mean voluntary) 30

31 UDI & GUDID Implementation Step 4 4. Submit Data A. Submit GUDID Data to FDA B. Verify GUDID Submission and Publication 31

32 4 Submit GUDID Data to FDA 32

33 4A Submit GUDID Data to FDA GO LIVE Submit Real Production Device Records For Manual, Individual Record Entry: Enter Draft data records via FDA GUDID Web Interface Select [Review] perform FDA data validation Perform Manual QC on data entry to ensure accuracy Select [Submit] send data to Unpublished / Published state depending the record s internal Published Date attribute For Automated, Bulk Entry: Create fully-valid SPL UDI files 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 high-speed, automated bulk transfers 33

34 4B Verify GUDID Submission and Publication Verify Web Interface Manual Submission - Verify records are Published per entered date & complete Grace Period Verify/Process FDA Acknowledgments (ACKs) to SPL Submissions Monitor and Collect FDA ACK messages - ACK 1 FDA receipt confirmation - ACK 2 CDRH receipt confirmation - ACK 3 CDRH validation results Pass or Fail (explanatory error message provided) Report ACKs and address omissions/errors Indicate GUDID Record Publication Status Unpublished Published-in-Grace-Period (30 days) Published-Final Retired (product taken off market) 34

35 4B Submission Lessons Item Errors to Avoid Comment 1 Incorrect GUDID Account Application information, e.g., Labeler & Submitter DUNS Check values and FDA setup 2 Duplicate submissions Records are rejected 3 Missing FDA submission ACKs Check FDA ACKs 4 Not reviewing data & updating prior to end of Grace period 5 Not including coreid in ACK3 Help Desk questions Unable to edit fixed fields in published GUDID records Capture and include coreid in Help Desk Tickets 6 Submitting close to Compliance Date FDA has exhibited delays 35

36 UDI Data Publically Available at NLM AccessGUDID 36

37 UDI & GUDID Implementation Step 5 5. Maintenance A. Start Production and Maintain Data & Systems B. Prepare for International UDI Submissions 37

38 5A Start Production and Maintain Data & Systems Start Production with UDI Confirm Device Record is Published in GUDID Cutover process to include UDI on Product and Packaging Labels and 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 notifications) 38

39 5A GUDID Device Record Maintenance GUDID Data Maintenance Timing Event Publication Time Requirement Label Change Non-Label Change FDA Notification of Error Publish GUDID record prior to Distribution Publish GUDID record within 10 days after Distribution Publish GUDID record correction or respond with explanation within 30 days after notification 39

40 5A GUDID Device Record Change Rules Record State Change Rules 1. Pre-GUDID Submission Change All Attributes 2. GUDID Draft (GUDID Web Interface only) Change All Attributes 3. GUDID Unpublished Change All Attributes 4. GUDID Published Grace Period Change All Attributes, except Publish Date 5. GUDID Published 6. GUDID Discontinued Change All Attributes, except: Pri DI Issuing Agency Primary DI Number Device Count Brand Name Version / Model Publish Date Sec DI Issuing Agency Secondary DI Number 40 Kit Combo Product Premkrt Exempt Single-Use Contains rubber Sterile Pkg Sterilization Reqd Note: some fields have special editing rules

5 Prepare for International UDI Submissions International Medical Devices

direction Group of Medical Device Regulators (Australia, Brazil, Canada, China,

) A single worldwide UDID is Not Expected Regional UDIDs are expected to

41 5 Prepare for International UDI Submissions 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 is Not Expected Regional UDIDs are expected to contain core information and have varying regional content Convergence, not Harmonization EU Medical Device Regulation (MDR) with UDI expected by mid

42 UDI & GUDID Implementation Summary 1. UDI Prep Create UDI Governance Team Research/Identify FDA UDI Requirements for Your Products Evaluate Your Situation & Applicable Exemptions/Extensions Define and Implement UDI Labeling Plan 2. GUDID System Prep Evaluate, Select, and Implement GUDID Solution Create FDA GUDID Accounts (all Labelers) Create FDA ESG Accounts (only SPL submissions) 3. GUDID Data Prep Collect Source GUDID Data Normalize and Validate Source GUDID Data 4. Submit Data Submit GUDID Data to FDA Verify GUDID Submission and Publication 5. Maintenance Start Production and Maintain Data & Systems Prepare for International UDI Submissions 42

43 UDI & GUDID Implementation Timeline UDI Plan UDI Labeling System Prep GUDID System Prep GUDID Data Prep Start UDI Product Production GUDID Submission Today Class II UDI Deadline July August September 6/8/2016 9/24/

Class II Devices Challenge Class II GUDID submission volume is estimated to be ~ twice the 2015 load Expect FDA GUDID submission process to be overloaded Expect delays: system downtimes and

44 Class II Devices Challenge Class II GUDID submission volume is estimated to be ~ twice the 2015 load Expect FDA GUDID submission process to be overloaded Expect delays: system downtimes and processing delays (ACK3 response normally 12 min was delayed for 3 days) Numerous smaller sized organizations will be submitting Expect FDA Help Desk overload Start UDI Process Now & Submit Early 44

45 GUDID Submission Solution Overview 45

46 Reed Tech GUDID Solution 46

Reed Tech UDI Solution Benefits Eases the Pain Accurate, Timely Submissions SME Support Least Intrusive Focused GUDID Submission Function Connects to Existing Systems Flexible SaaS/Outsourced Models

47 Reed Tech UDI Solution Benefits Eases the Pain Accurate, Timely Submissions SME Support Least Intrusive Focused GUDID Submission Function Connects to Existing Systems Flexible SaaS/Outsourced Models Scalable, Future OUS UDID Cost Effective Automated Bulk Submissions ESG Account, GUDID Testing Saves IT Cost (External Platform) Saves Time Fast Startup Data Merges & Transforms Proven & Compliant 145,000+ SPL Submissions 21 CFR Part 11 System UAT Environment, Audit Trail 47

Reed Tech has you covered Preparation, Submission, and Lifecycle Management

Over a decade of data validation and SPL submissions to the FDA Up-to-date

System Over 145,000 SPLs submitted to FDA GUDID FDA ESG AS2 connection for

all published FDA GUDID records* Roadmap to support international UDID

record) to large (250,000 records) customers 1 of the 3 largest medical

48 Reed Tech has you covered Preparation, Submission, and Lifecycle Management for Medical Device product UDI publication in FDA s GUDID Industry Experts Over a decade of data validation and SPL submissions to the FDA Up-to-date knowledge from guidance, trade groups, and pilots Proven, Current & Compliant System Over 145,000 SPLs submitted to FDA GUDID FDA ESG AS2 connection for automated, bulk SPL submissions Experienced, Major Industry Provider 25% of all published FDA GUDID records* Roadmap to support international UDID submissions Trusted Team Partner Over 140 medical device customers Small (1 record) to large (250,000 records) customers 1 of the 3 largest medical device manufacturers in the world Over 10 customers have international users 48 * As of May 1, 2016

49 NEW: Download Reed Our Tech Class DI Guide II UDI Submissions Guide Download this ebook to learn: How DIs are built How to obtain, assign and manage DIs Things to consider when choosing an issuing agency When a new DI is needed Where to go for more information CLICK HERE 49

50 Questions & Answers 50

51 Reed Tech Contact Information Josh Silvestri Life Sciences Sales Development Rep. Phone: +1 (215) Web: 52

52 Reed Tech Life Sciences Blog Blog: 53

53 Reed Tech UDI Resources Available from ReedTech.com: Class II Submissions Guide Reed Tech Class II Submissions Guide UDI Readiness Kit Reed Tech GUDID Data Element List UDI Training Course (in collaboration with Lernia Training Solutions) Available Upon Request: Sample GUDID Account Request Form Reed Tech GUDID Record Template 54

54 Industry UDI Resources FDA UDI Home Page UDI Rule, GUID Guidance, Compliance Dates, Resources efault.htm UDI Help Desk cm htm GUDID Information Basics, Guidance, Account Request, GUDID Web Interface, HL7 SPL, GUDID Status GlobalUDIDatabaseGUDID/default.htm GUDID Web Interface (Login) CDRH Resources (FDA Presentations: GUDID overview, account setup, etc.) ChangesbetweenUDIProposedandFinalRules/default.htm IMDRF EC Medical Devices 55

55 Medical Device UDI Glossary AIDC DI ESG GUDID GS1 Automatic Id and Data Capture technology used for automated product identification (typically 1D/2D barcode, RFID, near-field communication, etc.) Device Identifier static product identification (uniquely identifies company and product version) Electronic Submissions Gateway FDA agency-wide secure solution for accepting electronic regulatory submissions in electronic, bulk format FDA Global UDI Database registry of Medical Device DI and attributes 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 HL7 ICCBBA PI SPL UDI XML 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; Health Level Seven standards developing organization providing international healthcare information system interoperability standards for the exchange, integration, sharing, and retrieval of information 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); Production Identifier dynamic manufacturing information (i.e. batch/lot #, serial #, mfg. date, expiration date, and HCT/P code) Structured Product Labeling document markup standard (XML) approved by HL7 and adopted by FDA as a mechanism for exchanging product information Unique Device Identifier = Device Identifier (DI) + PI (Production Identifier) per approved Issuing Agency Extensible Markup Language markup language defining a set of rules for document encoding in both human and machine readable language. 56

UDI. Unique Device Identification. 9. Augsburger Forum für Medizinprodukterecht 12. September 2013, Augsburg. Copyright Fresenius Kabi AG 1

UDI. Unique Device Identification. 9. Augsburger Forum für Medizinprodukterecht 12. September 2013, Augsburg. Copyright Fresenius Kabi AG 1 UDI Unique Device Identification 9. Augsburger Forum für Medizinprodukterecht 12. September 2013, Augsburg Copyright Fresenius Kabi AG 1 UDI Agenda GHTF/IMDRF Framework EU Activities FDA Activities Implications