Under FDA regulations device labelers must generate a unique device identifier (UDI) for each of their products that are headed to market. This identifier will then be stored within the global unique identification database (GUDID) allowing for eased product lookup. However, certain class I and unclassified devices are not required to be a part of the GUDID. The UDI allows for eased tracking of devices that are in distribution from either human or machine-readable identifiers.
The UDI is composed of two main components, the device identifier (DI) and production identifier (PI). The DI is a mandatory and fixed portion of the UDI that identifies the labeler and the specific device model [1]. Whereas the PI is conditional and variable, based upon the type of device, such that, it could be an expiration date, manufactured date, serial number, lot/batch number, or a distinct identification code [1]. However, each UDI can either be based on a global standard 1 (GS1), health industry business communications council standard (HIBCC), or international council for commonality in blood banking automation standard (ICCBBA). Each of these three FDA accredited UDI formats can be used based upon the device type and/or company/labeler choice.
The ICCBBA standard is only used when labeling medical products of human origin such as blood cells and tissues and thus is a very specific standard for device labeling [2]. The GS1 standard utilizes a numeric DI delimited by ‘(01)’ and a numeric or alphanumeric for the PI. It is a very easily readable UDI that is more simplified than the HIBCC standard. The HIBCC standard utilizes an alphanumeric DI delimited by ‘+’ and an alphanumeric PI. Unlike the GS1 standard, the HIBCC allows for multiple identifier components in PI portion of the label.
If you need help determining the proper labeling of your device, or registering it in the GUDID per FDA compliance, the team of experts at EMMA International can help! Contact us today at info@emmainternational.com or by calling 248-987-4497.
[1] FDA. (2022, August 8). UDI Basics. U.S. Food and Drug Administration. https://www.fda.gov/medical-devices/unique-device-identification-system-udi-system/udi-basics
[2] ICCBBA. (2023). What is ISBT 128? Information Standard for Blood and Transplant. https://www.isbt128.org/
