Yesterday, we published a post on the Federal Drug Administration’s issuance of a final rule requiring that most medical devices distributed in the United States carry a unique device identifier (UDI). The rule also applies to certain combination products that contain devices and to devices licensed under the Public Health Service Act (e.g., donor screening assays).
What then, specifically, is a UDI?
A UDI is a unique numeric or alphanumeric code that consists of two parts:
- Device identifier (DI): a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device
- Production identifier (PI): a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of a device:
- 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 manufacturing date a specific device
- 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
This is what a UDI will look like on a medical device label:
As part of the UDI system, the FDA is also creating the Global Unique Device Identification Database (GUDID) that will include a standard set of basic identifying elements for each device with a UDI. Most of this information will be made available to the public so that users of a medical device can easily look up information about the device. The UDI does not indicate, and the database will not contain, any information about who uses a device or their personal information.
When fully implemented, the benefits of the UDI system promise to be significant; the system will:
- Allow more accurate reporting, reviewing, and analyzing of adverse event reports so that problem devices can be identified and corrected more quickly.
- Reduce medical errors by enabling health care professionals and others to more rapidly and precisely identify a device and obtain important information concerning the characteristics of the device.
- Enhance analysis of devices on the market by providing a standard and clear way to document device use in electronic health records, clinical information systems, claim data sources, and registries. A more robust post-market surveillance system can also be leveraged to support premarket approval or clearance of new devices and new uses of currently marketed devices.
- Provide a standardized identifier that will allow manufacturers, distributors, and healthcare facilities to more effectively manage medical device recalls.
- Provide a foundation for a global, secure distribution chain, helping to address counterfeiting and diversion and prepare for medical emergencies.
- Lead to the development of a medical device identification system that is recognized around the world.
For more information on the UDI system, including compliance dates for the requirement and accredited issuing agents, go here.