GS1 Healthcare US Implementation Guideline

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GS1 Healthcare US Implementation GuidelineApplying the GS1 System of Standards for U.S. FDA UniqueDevice Identification (UDI)Release 2.2, October 29, 2019

Implementation Guideline: Applying the GS1 System of Standards to U.S. FDA UDITable of ContentsDocument Summary . 5Part 1: Preface . 61.1.Introduction . 71.2.Document Symbol Legend . 71.3.Document Information . 81.4.Overview of the GS1 Standards Used. 101.5.Overview of the U.S. FDA UDI Rule . 121.6.Background Concepts . 15Part 2: UDI Device Identifier (DI) -- GS1 GTIN . 172.1Global Trade Item Number . 182.1.1Definition . 182.1.2Key Components . 182.1.3Family of Data Structures . 182.2Need to know . 192.3Determining Which GTIN Structure to Use for Your Device . 202.3.1Answer the following questions for each product . 202.4Family of GTIN Data Structure . 232.4.1GTIN-12 Structure . 232.4.2GTIN-13 Structure . 242.4.3GTIN-14 Structure . 252.5Sharing and/or Storing GTINs . 262.5.1Converting the GTIN structure to a storable/sharable format . 26Part 3: UDI Production Identifiers (PI) -- GS1 Application Identifiers . 283.1Introduction to GS1 Application Identifier (AIs) . 293.1.1GS1 Specification of the order of Application Identifiers . 293.1.2AI’s associated with the Production Identifiers for U.S. FDA UDI . 293.1.3General Guidance for Encoding AIs into GS1 Barcode . 303.1.4Understanding the AI Syntax . 303.1.5Manufacturing/Production Date: AI (11) . 313.1.6Expiration Date: AI (17). 323.1.7Batch/Lot Number: AI (10) . 333.1.8Serial Number: AI (21) . 34Part 4: UDI Labeling -- GS1 Barcodes. 354.1Overview of GS1 Barcodes . 364.2UDI AIDC Format and Encoding Principles: GS1 Barcodes . 384.2.1General Encoding Principles . 384.2.2GS1 Barcode Encoding Principles Further Defined . 394.2.3Encoding DI Only . 40R2.2 October 29, 2019 GS1 US ALL RIGHTS RESERVEDPage 2 of 62

Implementation Guideline: Applying the GS1 System of Standards to U.S. FDA UDI4.2.4Examples of Barcodes Encoding DI Only. 414.3Encoding DI and PI. 424.3.1Using a Single Barcode . 424.3.2Examples Encoding DI and PI Using a Single Barcode . 434.3.3Using Two Barcodes to Accommodate Point of Sale . 444.3.4Examples Encoding DI and PI Using Two Barcodes to Accommodate Point of Sale . 454.4GS1 HRI Rules . 464.4.1Location . 474.4.2Font . 474.4.3Printing and Expressing the Data . 47Part 5: UDI Direct Marking -- GS1 Standards for Permanently Marked Items (DirectPart Marking) . 495.1.GS1 Standards for Permanently Marked Items (Direct Part Marking) . 505.2.Direct Part Marking (DPM) Methods . 505.3.UDI Direct Marking in AIDC Format: GS1 Data Matrix . 515.4.Important Caveats . 51Part 6: Appendices . 526.1Additional Resources . 53GS1 US Resources: . 53GS1 Global Resources: . 53U.S. FDA Resources: . 546.2GTINs that Align with NHRIC/NDC . 546.2.1NHRIC/NDC Structure . 546.2.2GS1 Company Prefixes with NHRIC/NDC Labeler Codes . 556.2.3NHRICs/NDCs as GTINs . 556.2.4NHRIC/NDC aligned with a GTIN-12 . 566.2.5NHRIC/NDC aligned with a GTIN-14 . 566.3Introduction to GS1 US Data Hub Product . 57Part 7: Glossary of Terms and Definitions . 58R2.2 October 29, 2019 GS1 US ALL RIGHTS RESERVEDPage 3 of 62

Implementation Guideline: Applying the GS1 System of Standards to U.S. FDA UDIAbout GS1GS1 is a neutral, not-for-profit, global organization that develops and maintains the most widely-used supplychain standards system in the world. GS1 Standards improve the efficiency, safety, and visibility of supply chainsacross multiple sectors. With local Member Organizations in over 110 countries, GS1 engages with communitiesof trading partners, industry organizations, governments, and technology providers to understand and respond totheir business needs through the adoption and implementation of global standards. GS1 is driven by over amillion user companies, which execute more than six billion transactions daily in 150 countries using GS1Standards.About GS1 USGS1 US , a member of GS1 global, is a not-for-profit information standards organization that facilitates industrycollaboration to help improve supply chain visibility and efficiency through the use of GS1 Standards, the mostwidely-used supply chain standards system in the world. Nearly 300,000 businesses in 25 industries rely on GS1US for trading-partner collaboration that optimizes their supply chains, drives cost performance and revenuegrowth while also enabling regulatory compliance. They achieve these benefits through solutions based on GS1global unique numbering and identification systems, barcodes, Electronic Product Code (EPC )-based RFID, datasynchronization, and electronic information exchange. GS1 US also manages the United Nations StandardProducts and Services Code (UNSPSC ).About GS1 HealthcareGS1 Healthcare is a global, voluntary healthcare user group developing global standards for the healthcare supplychain and advancing global harmonization. GS1 Healthcare consists of participants from all stakeholders of thehealthcare supply chain: manufacturers, wholesalers, and distributors, as well as hospitals and pharmacyretailers. GS1 Healthcare also maintains close contacts with regulatory agencies and trade organizationsworldwide. GS1 Healthcare drives the development of GS1 Standards and solutions to meet the needs of theglobal healthcare industry, and promotes the effective utilization and implementation of global standards in thehealthcare industry through local support initiatives like GS1 Healthcare US in the United States.About GS1 Healthcare USGS1 Healthcare US is an industry group that focuses on driving the adoption and implementation of GS1Standards in the healthcare industry in the United States to help improve patient safety and supply chainefficiency. GS1 Healthcare US brings together members from all segments of the healthcare industry to addressthe supply chain issues that most impact healthcare in the United States. Facilitated by GS1 US, GS1 HealthcareUS is one of over 30 local GS1 Healthcare user groups around the world that supports the adoption andimplementation of global standards developed by GS1.R2.2 October 29, 2019 GS1 US ALL RIGHTS RESERVEDPage 4 of 62

Implementation Guideline: Applying the GS1 System of Standards to U.S. FDA UDIDocument SummaryDocument ItemCurrent ValueDocument TitleImplementation Guideline: Applying the GS1 System of Standards for U.S.FDA UDIDate Last ModifiedApril 11, 2019Document DescriptionThe purpose of this document is to provide sufficient information andguidance to support implementation of GS1 Standards for U.S. FDA UDI.Log of ChangesRelease Number – DateChangeR1.1 – Sept 14 2014Release/publicationR2.0 – Apr 11, 2019 Updated Template & Section NumberingAdded Document Symbol LegendPart 1: Updates throughout; Addedo 1.4 GS1 Company Prefixo 1.6.5 Barcode Scanners Part 2: Updates throughout and to GTIN data structure details; Addedo 2.1.2. Family of Data Structureso 2.2. Need to Knowo 2.3 Determining Which GTIN Structure to Use for Your Deviceo 2.3.1 Answer the following questions for each producto 2.3.1-1 Table: Barcode Options Based on Barcode Applicationo 2.4.2 GTIN-13 Sectiono 2.5 Sharing and/or Storing your DI Informationo 2.5.1 Converting the GTIN Structure to a storable/sharableformat. Part 3: Updates throughout; Addedo 3.1 Specification of the order of Application Identifierso 3.1.3. General Guidance for Encoding AIs into GS1 Barcodeo 3.1.4 Understanding the AI Syntax Part 4: Updates throughout; Addedo 4.1 Overview of GS1 Barcodes Sectiono 4.2 Title Updated and Important Noteo 4.4.3-1 Figure: General Guidance for HRI Placement Part 5: Updates throughout; Addedo 5.2-1 Table: GS1 Symbol Specification Table Part 6: Updates throughout; Addedo 6.3 Introduction Data HubPart 7: Added Glossary of Terms and DefinitionsR2.1 – June 28, 2019GS1 Barcode images updated throughoutR2.2 – October 29, 2019GS1 Barcode images updated throughoutNote: As with all GS1 Standards and solutions, this Implementation Guideline is voluntary,not mandatory. It should be noted that use of the words “must” and “require” throughoutthis document relate exclusively to technical recommendations for the proper application ofthe standards to support the integrity of your implementation.R2.2 October 29, 2019 GS1 US ALL RIGHTS RESERVEDPage 5 of 62

Implementation Guideline: Applying the GS1 System of Standards to U.S. FDA UDIPart 1: PrefaceR2.2 October 29, 2019 GS1 US ALL RIGHTS RESERVEDPage 6 of 62

Implementation Guideline: Applying the GS1 System of Standards to U.S. FDA UDI1.1. IntroductionOn September 24, 2013, the United States Food and Drug Administration (FDA) published a rule 1establishing a unique device identification system for medical devices. Under the rule, thehealthcare community and the public will be able to identify a device through a Unique DeviceIdentifier (UDI) that will appear on the label and package of a device. UDIs will be presented ondevice labels in both plain-text format and a format that can be read by automatic identificationdata capture (AIDC) technology (e.g., a barcode). In addition, re-usable devices that need to be"reprocessed" before reuse will also be directly marked with a UDI, allowing accurateidentification even when the device is no longer accompanied by its label or package. The UDI willprovide a standardized way to identify medical devices across all information sources andsystems, including electronic health records and devices registries. In addition, device labelerswill submit device information to a U.S. FDA database called the Global Unique DeviceIdentification Database (GUDID). The GUDID provides critical information about medical devices,and the UDI is the key for obtaining device information from the GUDID.GS1 is an FDA-Accredited Issuing Agency for UDI, and GS1 Standards are authorized for use inimplementing the requirements of the U.S. FDA UDI Rule. This Guideline was prepared by GS1Healthcare US to assist U.S. medical device trading partners implementing the U.S. FDA UDIRule using GS1 Standards. To that end, this document provides detailed guidance on how toapply GS1 Standards for U.S. FDA UDI.Important: GS1 US is not offering legal services or advice on the Company’s regulatorycompliance requirements. Each company is individually responsible for meeting all statutoryand/or regulatory requirements for their company and their products. Consult with yourcompany’s legal counsel or compliance team for more specific information about statutoryand regulatory requirements.Important: For the U.S. FDA rule, compliance schedule, and various U.S. FDA UDIresources, refer to this nandguidance/uniquedeviceidentification/1.2. Document Symbol LegendThroughout this document, you will find tips on best practices and notes containing additionalinformation. The icons listed below identify the kind of information being presented.SYMBOLMEANINGIndicates a reminder or important note.Indicates an informational note.Indicates a very important comment or note.1For information about the rule, see the United States Department of Health and Human Services. Food and Drug Administration (September 2013).Final Rule – Unique Device Identification System. 78 FR 58785. Retrieved on November 3, 2018 stemR2.2 October 29, 2019 GS1 US ALL RIGHTS RESERVEDPage 7 of 62

Implementation Guideline: Applying the GS1 System of Standards to U.S. FDA UDI1.3. Document InformationThis Guideline is based on the GS1 General Specifications, and was developed using informationobtained from all members of the U.S. healthcare supply chain, from manufacturers to providers.This version R2.0 has been updated to include new information announced by the U.S. FDA.Additional information from U.S. FDA comes in the form of Draft Guidance, Final Guidance,extensions or modifications to aspects associated with some UDI requirements. Please refer tothe U.S. FDA UDI website for more information on these m1.3.1. PurposeThe purpose of this document is to provide a foundation for the appropriate use of GS1identification and barcode standards on medical devices within the context of the U.S. FDA UDIRule. This Guideline does not provide any guidance or advice regarding regulatory compliance.1.3.2. AudienceThis Guideline was written primarily for manufacturers/suppliers. Nonetheless, it provides basicinformation that may be useful to the entire healthcare supply chain from the label printer to thehealthcare provider for understanding the application of GS1 Standards for U.S. FDA UDI.1.3.3. ScopeThis Guideline identifies the GS1 identification and barcode standards that correlate to U.S. FDAUDI Rule requirements, and explains how to implement these standards within the context of theU.S. FDA UDI Rule. It does not provide any guidance or advice regarding regulatorycompliance. Federal requirements for unique medical device identification in the U.S. arespecified in the U.S. FDA UDI Rule and subsequent FDA Guidance(s).Important: Each company is individually responsible for meeting all statutory and/orregulatory requirements for their company and their products. Consult with your company’slegal counsel or compliance team (regulatory or quality) for more specific information aboutcurrent statutory and regulatory requirements applicable to your company and products.This document covers the following topics:Table 1.3.3-1: Elements of the U.S. FDA UDI Rule with corresponding GS1 Standard(s)ELEMENTS OF THE U.S. FDA UDIRULEAPPLICABLE GS1 STANDARD(S)DEVICE IDENTIFIER (DI)GS1 Global Trade Item Number (GTIN )PRODUCTION IDENTIFIERS (PI)GS1 Application Identifiers (AIs)REPRESENTATION OF UDI IN AIDC ANDEASILY READABLE PLAIN TEXT FORMATGS1 Barcodes and Human ReadableInterpretation (HRI)DIRECT MARKING UDI ON DEVICESGS1 Rules for Permanently marked itemsGUDID DATA SUBMISSIONGS1 Global Data SynchronizationNetwork (GDSN )R2.2 October 29, 2019 GS1 US ALL RIGHTS RESERVEDPage 8 of 62

Implementation Guideline: Applying the GS1 System of Standards to U.S. FDA UDI1.3.4. Normative ReferencesThis implementation guideline is based on the GS1 General Specifications. The specific standardsreferenced in this guideline are listed below, and the relevant provisions of thesestandards/specifications are to be considered provisions of this guideline:-GS1 General Specificatio

healthcare industry through local support initiatives like GS1 Healthcare US in the United States. About GS1 Healthcare US GS1 Healthcare US is an industry group that focuses on driving the adoption and implementation of GS1 Standards in the healthcare industry in the United States to help improve patient safety and supply chain efficiency.

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