I recently returned from the 2019 UDI Conference in Baltimore. It’s one of my favorite conferences because it is co-sponsored and heavily attended by the Unique Device Identification (UDI) team of the U.S. Food and Drug Administration (FDA). You can get your UDI questions answered directly by those responsible for administering the regulations. The FDA UDI team even has a booth in the tradeshow. Compared with the drug side of the FDA, this is unheard of, and device labelers and packaging professionals should take advantage of this annual event.
But the event is over for this year. So how can device packaging professionals get the information they need to meet the UDI regulations right now? Use Healthcare Packaging’s UDI Resource Guide as a launching pad to find everything you need to stay in compliance.
We’ve collected all the links you’ll need whether you are using GS1, HIBCC or ICCBBA as your number issuing agency. Plus, all the links are annotated to help you narrow your search before you start clicking.
UDI BACKGROUND
Unique Device Identification was originally proposed in the early 2000s through a global harmonization effort organized by the World Health Organization and attended by a group of national regulators from markets around the world. The goal of that effort was to facilitate “…a convergence in standards and regulatory practices related to the safety, performance and quality of medical devices.” The group published “Medical Device Regulations, Global overview and guiding principles” in 2003, which established a blueprint for harmonized national regulations of medical devices.
In 2011, the regulatory agencies who participated in the WHO effort started the International Medical Device Regulators Forum (IMDRF) to build on the foundational work of the WHO. In August of 2012 the FDA was the first member of IMDRF to publish proposed rules for a unique identifier for medical devices and the associated regulations that included many elements of the original WHO blueprint. The FDA published the UDI Final Rule on September 24, 2013.
Since then the European Union has published a very similar regulation and the regulatory concept appears to be sweeping the world. Countries that are in various stages of work on future UDI regulations that use the WHO blueprint include Turkey, Columbia, China, Saudi Arabia, South Korea, Russia, Japan, Australia and others.
Considering the focus of these efforts, the original goal of global regulatory harmonization for UDI has largely been met, but every UDI regulation is still different, reflecting local regulatory norms and existing laws. Device manufacturers, labelers and packagers need to know the specifics of each regulation in the markets they target.
UDI RESOURCE GUIDE IN THE U.S.
The U.S. regulation contains specific requirements for device identification, labeling and product data registration. This typically involves many departments within the organizations of device manufacturers/labelers, contract manufacturers and contract packagers. We hope these resources help you understand the regulation, the requirements you are facing and the technologies available to meet them.
We've broken our list down by the primary sources: The FDA, the three current FDA accredited number issuing agencies and a few other sources. We’ve also broken it down by general UDI background resources, device identification resources, labeling resources and product data registration resources.
FDA GENERAL UDI RESOURCES
The U.S. FDA provides a wealth of information and guidance about the regulation and how to meet it.
FDA’s main UDI page
The main FDA web page for UDI is a great place to start any search for information about the regulation. Note the helpful quick-links along the margins. You can also sign up for FDA’s email list for updates on UDI at the bottom of the page.
UDI Basics
This is a good high-level explanation of the UDI requirements.
Compliance Dates for UDI Requirements
A great page that breaks down all the deadlines for compliance by device type, including devices that are exempted. That’s right, there is a deadline, even for devices that are exempt from the UDI rule! Most deadlines are in the past, which means these devices must comply today.
UDI Exceptions, Alternatives and Time Extensions
An FDA page with information about the various exceptions, alternatives, FDA Decisions and time extensions offered by the FDA after the final rule was published. Make sure you check this page before you implement.
UDI Rule and Guidances, Training, Resources, and Dockets
FDA-compiled page with links to all the existing UDI-related FDA guidance and rules, training Dockets and other resources.
Unique Device Identifier System: Frequently Asked Questions, Vol. 1
This is a “final guidance” document with answers to 33 different questions you might have about UDI in the U.S.
FDA UDI Resources Page
Here’s the link to FDA’s own UDI Resources page.
FDA UDI Help Desk
Still have a question? Use this page to submit a question to the FDA UDI Team.
DEVICE IDENTIFICATION RESOURCES
Fundamentally, UDI is about standardizing the identification of devices. The requirement is that every type and variation of a device must have a single, standardized way of identification—an identifier that the FDA and companies in the supply chain will use to refer to that specific model and variation.
The UDI rule breaks identifiers into two categories: a “device identifier” (DI) and “production identifiers” (PI). Each type/variation of a device must have one DI. PIs include lot numbers, serial numbers and software version numbers. Every production unit of a device introduced into the supply chain must have at least one PI associated with it. Additional PIs are optional.
Device labelers must choose at least one of three FDA-accredited “number issuing agencies” to obtain the DI that will be used to refer to their device. It is possible, though rare, to use more than one number issuing agency to define multiple DIs for a single device. The three agencies are GS1, the Health Industry Business Communications Council (HIBCC) and ICCBBA.
Labelers of medical products of human origin should use ICCBBA as their number-issuing agency because their identifiers incorporate special features that enable a linkage to donors. Labelers of other types of devices may choose either GS1 or HIBCC.
FDA DI RESOURCES
Contact an FDA-Accredited Issuing Agency
FDA page with all the contact information for the issuing agencies.
UDI Formats by FDA-Accredited Issuing Agency (January 27, 2017)
FDA page with information about the UDIs—both DIs and PIs—issued by each of the issuing agencies.
GS1 DI RESOURCES
GS1 Standards Resources for U.S. FDA UDI Implementation Support
GS1’s main UDI resources page. Start here when you are evaluating or using GS1 standards for FDA UDI compliance.
Healthcare Supplier FDA UDI Quick Start Guide
A high-level overview of the U.S. UDI regulation and the steps to become compliant using GS1 standards.
GS1 Guide on Unique Device Identification (UDI) implementation in the USA and in the EU
Another overview—this one published by GS1 (global)—of UDI concepts with emphasis on meeting the U.S. and EU UDI regulations using GS1 standards.
Implementation Guideline – Applying the GS1 System for U.S. FDA Unique Device Identification (UDI) Requirements
Indispensable information for labelers using GS1 standards for U.S. UDI compliance.
U.S. FDA Unique Device Identification (UDI) Rule Frequently Asked Questions (FAQs)
Despite the title, this is an FAQ document published by GS1 Healthcare US. It contains questions and answers about the FDA UDI rule in general, and how to apply GS1 standards for meeting it.
GS1 US FDA UDI Rule: Education and Implementation Resources
A web page with links to GS1 resources for evaluating and using GS1 standards for FDA UDI compliance.
Standards Guidance for Assigning DIs Using Global Trade Item Numbers (GTINs)
Important technical guidance for creating GS1 GTINs that meet your needs and meet the DI requirements of the U.S. FDA UDI Rule.
GS1 DI Check Digit Rules
A GS1 DI is a GS1 Global Trade Item Number (GTIN). This page provides an online calculator to calculate the necessary check digit.
HIBCC DI RESOURCES
Apply for a Labeler Identification Code (LIC)
To create HIBCC UDI identifiers, you must obtain an HIBCC Labeler Identification Code (LIC). Once you have an LIC, you can create your own HIBCC-based UDI identifiers using the HIBCC Health Industry Bar Code (HIBC) standard.
HIBCC UDI and Labeling Resource Center
A collection of all the links you will need to create and use HIBCC UDI DIs and PIs in product labeling. This is a great place to start evaluating and using HIBCC standards for UDI.
How to Become FDA UDI Compliant: Getting Started: HIBCC's Guide to UDI Compliance
A document with the six steps you need to follow to get started using HIBCC for FDA UDI compliance. Each step includes a link to the resources you need.
HIBC Supplier Labeling Standard (SLS) 2.6
Indispensable document explaining the technical details of using the HIBC standard for creating and using UDI DIs and PIs.
HIBCC DI Check Digit Calculation
The HIBCC DI is an HIBCC Label Item Code (LIC). This document explains how to calculate the necessary check digit.
ICCBBA DI RESOURCES
ISBT-128 GRID Checksum Calculator
The ICCBBA DI is encoded using ISBT 128. This page explains the check digit calculation.
What is ISBT 128?
A web page with text and video explanation of the ISBT 128 standard and how it is used.
Frequently Asked Questions
FAQs for ISBT 128.
Unique Device Identifier (UDI) Generator
A downloadable spreadsheet that helps labelers construct the ISBT 128 code suitable for use as a DI.
Device Identifier Checker
A downloadable spreadsheet thatallows you to parse the various elements of an existing ISBT 128 DI.
Multiple Device Identifier Checker
A downloadable spreadsheet that allows you to parse the various elements of a list of existing ISBT 128 DIs.
OTHER DI RESOURCES
IMDRF: Unique Device Identification system (UDI system) Application Guide
Remember, IMDRF does not set requirements for the U.S., but these may be helpful in understanding what might be coming in future updates to the UDI regulation.
RxTrace: FDA Proposed UDI: A Revolution In Number Assignment
A little dated, but still valid explanation of the UDI rule when it was just an FDA proposed rule.
LABELING RESOURCES
Many UDI resources discuss labeling in just a section of a larger document so please check many of the resources listed in other sections. The resources below (many of which are mentioned above) include at least one example of a UDI-conformant device label as an example.
FDA LABELING RESOURCES
UDI Basics
A good high-level explanation of the UDI requirements, including an explanation of a UDI product label.
Unique Device Identifier System: Frequently Asked Questions, Vol. 1
This is a “final guidance” document with answers to 33 different questions you might have about UDI in the U.S.
Unique Device Identification (UDI)
FDA presentation outlining the UDI regulation and requirements, including at least one example label image.
GS1 LABELING RESOURCES
GS1 Guide on Unique Device Identification (UDI) implementation in the USA and in the EU
An overview—this one published by GS1 (global)—of UDI concepts with emphasis on meeting the U.S. and EU UDI regulations using GS1 standards.
Sample UDI Labels
Three example UDI labels emphasizing the use of GS1 standards.
HIBCC LABELING RESOURCES
HIBCC UDI and Labeling Resource Center
A collection of all the links you will need to create and use HIBCC UDI DIs and PIs in product labeling.
HIBCC UDI Compliant Label Examples
A document that shows examples of several UDI-compliant labels that use HIBCC DIs and PIs.
How to Use HIBCC Date Formats for UDI
A document that explains how to use the HIBCC formats under the FDA UDI regulation.
ICCBBA LABELING RESOURCES
ISBT 128 STANDARD: Coding and Labeling of Medical Devices Using ISBT 128
The definitive explanation for how to apply ISBT 128 to meet the U.S. FDA UDI final rule.
Product Description Code Request Form - HCT/P Medical Device
Start here to begin labeling human cells, tissues, and cellular and tissue-based products (HCT/P) that must be registered with the FDA as medical devices.
Medical Devices - Documents
Web page listing documents explaining the use of ISBT 128 to meet the U.S. UDI regulation.
UDI Labelers
Webpage with information and links pertinent for labeling medical devices with ISBT 128 to meet the U.S. UDI rule.
Label Examples - HCT/P Medical Devices
Webpage with examples of medical device labels using ISBT 128 for UDI.
OTHER LABELING RESOURCES
IMDRF: Principles of Labelling for Medical Devices and IVD Medical Devices
Remember, IMDRF does not set requirements for the U.S., but these may be helpful in understanding what might be coming.
2017 UDI Conference, AIM North America: Your Morning Dose of UDI Fundamentals
A presentation covering information about UDI including multiple examples of UDI labeling.
RxTrace: FDA Proposed UDI: AIDC Requirements
A little dated, but still valid explanation of the AIDC requirements of the UDI rule when it was just an FDA proposed rule.
REGISTRATION REOURCES
Registration means submitting your medical device DI and its associated product data to the FDA Global UDI Database (GUDID). GUDID is a database administered by the FDA that serves as a reference catalog for every device with a unique device identifier (UDI). GUDID may be accessed by industry and the public through the AccessGUDID website.
FDA REGISTRATION RESOURCES
Global Unique Device Identification Database (GUDID)
FDA page listing FDA resources for GUDID.
Global Unique Device Identification Database (GUDID) User Manual
Indispensable guide for getting started registering your medical devices on the GUDID database.
GUDID Guidance
FDA downloadable document containing valuable guidance explaining the GUDID database and how to interact with it as an FDA-licensed medical device labeler. Don’t miss the section on the Global Medical Device Nomenclature (GMDN) and how it fits into your submissions.
GUDID Data Elements Reference Table
This document lists all the various master data elements—including some very helpful data entry notes—you might need to include in your GUDID submissions.
HL7 SPL Implementation Files
A zip file containing everything you’ll need to submit your GUDID data records using Health Level 7 (HL7) Structured Product Labeling (SPL) XML files, including example files and the complete HL7 SPL Implementation Specification.
Prepare for GUDID
A checklist for preparing to submit your medical device product master data for your DIs to the GUDID database.
Request a GUDID Account
Application form for requesting an account that can be used to submit your medical device product master data for your DIs to the GUDID database.
Submit Data to GUDID
FDA information about submitting your medical device product master data for your DIs to the GUDID database. This page provides information about manual data entry through the GUDID Web Application and submitting with HL7 SPL files.
GUDID Data Submission Portal
This is where you use your existing GUDID account to submit your product master data to the GUDID database.
GS1 REGISTRATION RESOURCES
Leveraging GDSN for the FDA Global Unique Device Identifier Database (GUDID) Implementation Guideline
Detailed explanation of how to make use of the GS1 Global Data Synchronization Network (GDSN) infrastructure to securely supply data about your medical devices to the FDA Global Unique Device Identification Database (GUDID).
HIBCC REGISTRATION RESOURCES
HIBCC’s Guide to GUDID Device Identifiers
Guide explaining how to apply the HIBC UDI codes for compliance with the UDI rule and for uploading data into the FDA GUDID database.
ICCBBA REGISTRATION RESOURCES
Unfortunately, ICCBBA offers no specific information about how to register your ICCBBA-labeled medical devices in the FDA GUDID database.
ISBT 128 STANDARD: Coding and Labeling of Medical Devices Using ISBT 128
The definitive explanation for how to apply ISBT 128 to meet the U.S. FDA UDI final rule.
OTHER REGISTRATION RESOURCES
IMDRF: Non-In Vitro Diagnostic Device Market Authorization Table of Contents (nIVD MA ToC)
Remember, IMDRF does not set requirements for the U.S., but these may be helpful in understanding what might be coming.
IMDRF: In Vitro Diagnostic Medical Device Market Authorization Table of Contents (IVD MA ToC)
GMDN Agency: GMDN Agency
The homepage of the organization that maintains the medical device nomenclature that must be used when describing your devices in the FDA GUDID database. The agency is identified in the UDI Final Rule as the official supplier of the nomenclature used in the database.
RxTrace: FDA Proposed UDI: The GUDID Database
A little dated, but still valid explanation of the GUDID database requirements of the UDI rule when it was just an FDA proposed rule.
