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A Unique Device Identifier (UDI) is a numeric or alphanumeric code that is assigned to a medical device. These codes are entirely unique, designed as a method to easily identify and determine the use of devices sold in the United States and Europe. The purpose of a UDI is to enable the regulatory agencies, industry, device users, and healthcare systems to be able to recognize devices from manufacturing through distribution to patient use.

In the U.S., in an effort to improve the process for identifying a device and reduce medical errors, UDI information is submitted to the Global Unique Device Identification Database (GUDID). The GUDID is an FDA managed, publicly accessible database that serves as a catalog of all devices with a UDI. This database allows the FDA, the medical device industry, and healthcare providers to easily access information regarding the device. All devices that require a UDI on the label, package, or device must enter information into the Global UDI database.

The UDI may consist of plain text (human readable) and AIDC (machine readable) and is composed of two parts:

  • Device Identifier (DI) – A unique numeric or alphanumeric code specific to a device version or model.
  • Production Identifier(s) (PI) – Numeric or alphanumeric codes that identify production information for a device and can include the following:
    • Lot or batch number;
    • Serial number;
    • Expiration date;
    • Manufacturing date;
    • Distinct identification code (for Human Cell and Tissue).

UDI example for illustrative purposes only (FDA).

As September 24, 2020, one of the last phases of FDA’s compliance dates for UDIs, approaches, all “Class I devices, and devices that have not been classified into class I, class II, or class III that are required to be labeled with a UDI, must a bear UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use.” This includes software regulated as a Class I medical device (SaMD).

It is important to note that:

  • Class I and unclassified implantable, life-supporting or life-sustaining devices should already be in compliance with UDI requirements.
  • Class I cGMP exempt devices are excepted from UDI requirements per 21 CFR 801.30(a)(2).
  • Class I and unclassified devices manufactured and labeled before September 24, 2018, are excepted from the UDI labeling and GUDID submission requirements until September 24, 2021, per CFR 801.30(a)(1).

UDIs are issued by private FDA-accredited organizations which are permitted to assign UDIs according to the Unique Device System final rule (21 CFR Part 830). If you are a device labeler—any person who applies a label to a device, or who causes the label of a device to be modified, with the intention to commercially distribute the device without any subsequent replacement or modification of the label—an UDI must be obtained (with above noted exceptions) no later than September 21, 2020, concomitant with the information being submitted to GUDID.

The procurement of UDIs is a complicated and tedious process. Attention needs to be given to all the different puzzle pieces in order for your company to sufficiently comply with FDA’s regulations. To guarantee that your products will not be misbranded, it is time to start obtaining UDI numbers for your devices and registering those numbers with GUDID.

Contact the experts at MEDIcept for all your UDI labeling needs, including:

  • Clarification if you are a considered labeler under FDA regulations,
  • Assistance in comprehending your UDI requirements,
  • Regulatory assessment of your labeling, FDA registration and device listing, or
  • Development of a complete labeling strategy.