FDA’s Unique Device Identification (UDI) System for Medical Devices
20 Jul 2024
One of the most crucial aspects of the medical device manufacturing market is ensuring integrity of the supply chain of the products. Not only that, but having a simple knowledge of products’ manufacturers, model of the device, and their expiry date, etc. are also important. For this purpose, the US FDA has established a Unique Device Identifier (UDI) system.
What is the UDI?
Unique Device Identification is a numeric or alphanumeric code created by the product owners and is assigned to each medical device, which makes it easy to track its manufacturer, model, and expiry date. Another major benefit of UDI is standardization of device documentation in clinical systems and electronic health records. The UDI comprises:
- Device Identifier (DI): It is the mandatory fixed portion of the UDI used for identification of the labeler. It also identifies the version and specific model of the device. DI includes information regarding the device’s labeler/manufacturer, its unique serial number, and product code.
- Production Identifier (PI): PI is the conditional and variable portion of the UDI containing information about device’s production, such as its batch number, manufacturing date, and expiration date.
PI can also include a distinct identification code as required by §1271.290(c) for
- a human tissue,
- cell, or
- cellular and tissue-based product (HCT/P) being regulated as a device.
Using this information, it becomes easier to track origins of the device while also ensuring quality control.
How should the UDI be Provided?
UDI should be provided by the device labeler in two forms on packages and labels:
- Machine readable form that utilizes the AIDC (Automatic Identification and Data Capture) technology, and
- Easily readable plain text format.
How to Present Dates on the UDI?
The device labelers are required to present dates on device packages and labels in a standard format to be consistent with international practice and standards (YYYY-MM-DD).
What is AIDC?
AIDC (Automatic Identification and Data Capture) is any technology that conveys a device’s UDI or DI in a form that can be automatically entered into a computer system or electronic patient record.
Also, read about EU MDR UDI compliance requirements.
Impacts of the UDI System on Supply Chain Management of Medical Devices
The UDI system has a lot of positive impacts of the supply chain management of the medical devices. These include:
- Inventory Management
UDI makes inventory management efficient. With its help, manufacturers can identify and reduce errors, ensure optimization of stock, and prevent their stocks from emptying.
- Traceability
UDI ensures precise tracking of the medical devices across their supply chain. Each stage of the supply chain, from manufacturing of the device till its distribution, can be traced along with device’s location and movement.
- Recall Management
If any product recalls (or safety alerts) are issued, then faulty and erroneous devices can be swiftly located with the help of UDI. Once located, such product(s) can be promptly removed from the circulation, thus preventing any harmful exposure to the patients.
- Preventing Counterfeit Products
UDI verification can separate an authentic device from a fake device. Again, this aspect ensures patient safety as they are only provided with the genuine devices.
- Compliance with Regulations
Medical device manufacturers who incorporate UDI in their products also fulfill the requirements of US FDA, thus enabling themselves to market their devices in the US market.
Requirements of US FDA Regarding UDI Labeling
The Unique Device Identification System final rule (UDI Rule) presents the following two requirements in front of device manufacturers and labelers:
First Requirement
Manufacturers should include a UDI on their device’s labels and packages. However, they can go for the exception or alternative, wherever allowed by the rule. Moreover,
- if the device is meant for more than one use, or
- if it intended to be reprocessed for reuse, then
The device labeler must mark the UDI directly on the device.
Second Requirement
The device information should be submitted to the Global Unique Device Identification Database (GUDID).
Requirement for Submitting Information to the GUDID (Global Unique Device Identification Database)
Another important requirement that device labelers should fulfill issubmitting information to the FDA-administered GUDID. GUDID only contains the Device Identifier to help obtain essential information from the database. This standard set of basic identifying elements is reserved only for devices with a UDI.
The Access GUDID Database:
FDA has partnered with the National Library of Medicine to offer AccessGUDID. It is a separate and searchable database used for device identification information for patients, healthcare providers, caregivers, industry, and hospitals, etc.
AccessGUDID allows users to
- Search quickly for devices by their name, device identifier (DI), or company.
- Conduct advanced searches by combining other fields in the database.
- Download the data and export their search results.
Who is a Device Labeler?
A device labeler is someone who causes a label to be affixed to a device, or who causes the label of a device to be modified, with the intent that the device would be commercially supplied without any later replacement or modification of the label.
The device manufacturer would typically be the labeler, but other possible labelers include specification developers, re-processors for single-use devices, convenience kit assemblers, repackagers, and relabelers.
Alternatives and Exceptions to the UDI Rule
The UDI Rule has certain exceptions to the UDI requirements. For this purpose, manufacturers can refer to 21 CFR 801.30, 801.40(d), and 801.45(d). The UDI Rule also provides labelers with a process with which they can submit a request for an alternative or an exception to a UDI requirement. 21 CFR 801.55 can be consulted.
Complying with Dates and Requirements for UDI
As of now, the UDI system is being implemented in phases to ensure its smooth implementation. With FDA going through the last phase of the implementation, it is mainly working on the low-risk devices and with time, this implementation will be completed.
Looking for UDI Compliance? We can help!
Fulfilling UDI requirements means that manufacturers take FDA requirements seriously. Moreover, such manufacturers can easily produce and place their products in the US market. At TS Quality and Engineering, we have professionals with an ample knowledge of FDA’s UDI requirements. By visiting tsquality.ch, and contacting us you can collaborate with them and get your devices placed in the US market today!
