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The FYI on UDI

It has been five years since the Food and Drug Administration (FDA) released a final rule establishing a unique device identification (UDI) system for the medical device industry.

The benefits are numerous and include more accurate reporting of adverse events, a reduction in medical errors, and more effective management of medical device recalls. But UDI’s full integration in regards to the numerous types of medical devices is also complex.

With few exceptions, all labelers (in most cases, the manufacturer) must include a UDI on device labels and packages in both a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology. With some exceptions, the device must also be directly marked if it is intended for reuse on different patients and will be reprocessed before each use. These unique numeric or alphanumeric codes must have a Device Identifier (DI) portion that identifies the labeler and the version or model of the device. This section needs to be submitted to the Global Unique Device Identification Database (GUDID). For most Class II and III devices, there must also be a Production Identifier (PI) that identifies one or more of the following:

  • The lot or batch number within which a device was manufactured
  • The serial number of a specific device
  • The expiration date of a specific device
  • The date a specific device was manufactured
  • The distinct identification code required by §1271.290(c) for a human cell, tissue, or cellular and tissue-based product (HCT/P) regulated as a device

The UDI directly marked on the device may be the same as the UDI on the label, or the labeler may choose a different UDI to distinguish the unpackaged device from any device package containing the device.. Unlike the UDI on labels and packages, the UDI direct mark may be provided through either easily readable plain-text or an automatic identification and data capture (AIDC) technology (or any alternative technology that will provide the UDI of the device on demand), or both.

All UDIs must be issued under a system operated by an FDA-accredited issuing agency. The FDA does not specify any particular approach to directly mark devices, because it would be difficult to account for the wide variety of existing devices, use conditions, and reprocessing methods for these devices. However, the agency does expect that the direct mark UDI should last throughout the expected service life of the device, taking into account expected usage and reprocessing according to the instructions of the manufacturer. In deciding the form or forms of the UDI for direct marking, labelers should consider factors such as technological feasibility, efficiency for the end user, and risk of human error.

Three compliance dates have already come and gone, with another coming up in just weeks. On September 24, 2018, the rule regarding Class II devices that will be used more than once and reprocessed before each use will go into effect. In addition, labels and packages for Class I devices and those that have not been classified will require a UDI, in which the compliance date is set for September 24, 2020. As medical device companies face continued challenges with innovation, quality control, and cybersecurity, that date may seem like a long way off. But with so much complexity involved in UDIs, it is important for manufacturers to prepare in advance and consult experts when they need assistance maintaining regulatory compliance.

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