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.

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