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The FDA established the unique device identification system to adequately identify medical devices sold in the United States from manufacturing through distribution to patient use. When fully implemented, the label of most devices will include a unique device identifier (UDI) in human- and machine-readable form, which will ultimately improve patient safety, modernize device post market surveillance, and facilitate medical device innovation.

The U.S. FDA requires medical device labelers to:

• Include Unique Device Identifiers (UDI) on their device labels
• Submit device information to the Global Unique Device Identification Database (GUDID)
• Designate a Regulatory Contact for UDI purposes

The Unique Device Identification System, commonly referred to as UDI, is a Food and Drug Administration (FDA) rule that requires medical device labelers to mark medical packages and devices with a unique barcode. These labels aid supply chain and healthcare professionals in accurately identifying of medical devices during transit and use.

The responsibility for UDI compliance falls largely on device labelers, who must include a unique device identifier on all non-exempt medical devices and packages. UDI barcodes are composed of two parts. The device identifier (DI) indicates the labeler and device model, while the production identifier (PI) may indicate batch number, serial number, manufacture date, or expiration date. The FDA’s final rule includes several exceptions and alternatives for certain devices, in order to minimize the cost of burden placed on labelers. 

UDI labels must be applied to medical devices or stand-alone software that are deemed life-sustaining, life-supporting, or implantable. A UDI label must be applied permanently to the body of the device if it is designed to be used more than once.

Class III medical devices must bear a UDI on the device itself if designed to be used more than once. The packaging and labels of all class II medical devices and class II stand-alone software must have UDI labels. 

Class II devices that are intended to be used multiple times must have a UDI directly on the device. The packaging of class I medical devices, class I stand-alone software, and any medical devices that are not categorized in class I, II or III must have UDI labels.

Class I medical devices must have a UDI on the body of the device if it will be used multiple times. This also applies to all medical devices that do not fall into class I, II or III. 

After receiving numerous requests for extensions, the FDA has extended the deadline for the direct marking of Class I and unclassified medical devices. UDI labeling and GUDID data submission for these devices still fall under the 2020 deadline. 

Labelers and Medical Devices

Device labelers must include a unique device identifier on all non-exempt medical devices and packages that are sold in the United States. Depending on the type of device, these UDI barcodes must be placed on the body of the medical device and/or on the device packaging.

Labelers are most often the device manufacturers, but that is not always the case. The labeler could also be a repackager, reprocessor, relabeler, kit assembler, or specification developer. Whether or not a company is responsible for a UDI label depends on what type of medical device they process and where in the supply chain they handle it.

The device identifier (DI) should be placed on the device label in machine readable form. The production identifiers (PI) that are selected should be included, and both should be machine and human readable. The format for any human readable dates should be in the required format.

Accredited Agency

The device manufacturer does not assign the device identifier (DI). Instead, it comes from an organization accredited by FDA. These organizations are called accredited agencies or, because they issue the DI, issuing agencies. To date, FDA has accredited three agencies: GS1, Health Industry Business Communications Council (HIBCC), and ICCBBA.

The accredited agency that is selected should be a supplier that provides a service. User should make sure that user have implemented the requirement, evaluation, and selection process in 21 CFR 820.50.

Components of UDI:

1. Device Identifier
2. Lot number
3. Serial Number
4. Manufacture Date
5. Expiration Date

Comparison of UDI with globally accepted standards

Compliance with UDI involves a three-pronged approach:

1. Project planning: There needs to be well thought out project plan that includes analyzing product offerings that the company has and gathering certain information about each product. It has to have marketing authorization from FDA, the product code, and listing numbers, and then you have to determine (for each product) all the production information that you attach for each product. Once the information is gathered together, one of the issuing agencies that FDA authorizes must be selected. Then the barcodes that will go on the product needs to be designed so as to provide appropriate information.

2. Process: Existing processes within the organization needs to be taken care and should determine what type of labeling, printing, acquisition and suppliers, and what kind of controls on labeling will be required; what printing or labeling mechanisms are being used in manufacturing lines now and do they need updates or changes, etc.

3. Reporting into the GUIDID [Global UDI Database] itself: Determining the information that has to be downloaded into GUIDID. There’s a lot of being done across the organization, involving regulatory, quality, manufacturing, operations, and the IT department, and management needs to give firm support to the projects.

4. Each of these organizations has a required format for the UDI. The details can be seen in the document UDI formats by FDA-Accredited Issuing Agency.

5. GS1 – 14 numeric characters; HIBCC – 6 to 23 alphanumeric characters; ICCBBA – 18 alphanumeric characters

6. In addition to the data structure, the accredited agencies may allow (or restrict) the data carrier. Generally, the data carrier implements automatic identification and data capture (AIDC). The data carrier is the method used to present the machine readable information. Allowed data carriers include linear bar codes, 2D bar codes, QR codes, RFID chips, etc. FDA does not specify the data carrier; the device manufacturer decides based on what customers can read and what the accredited agency allows. However, if the customer cannot read it, there is little value in this approach. It appears that the vast majority of manufacturers will implement linear bar codes.

7. The Date Format

The rule requires that human readable dates conform to a standard format to avoid confusion and misleading users. The standard format, in most cases, uses year-month-day (e.g., 2013-09-30). The exception is the date of manufacture for electronic products that FDA regulates. In 21 CFR 1010.3(a)(2)(ii) the required date format is the month without abbreviation and the year as a four-digit number (e.g., Manufactured: September 2013).

8. One important point is that the AIDC may include dates using characters. For example, there are often printed characters under a linear bar code. These dates are part of the AIDC as specified by the issuing agency. FDA does not regulate how the AIDC communicates data; these dates do not have to be in the human readable date format

The Unique Device Identification (UDI) System will benefit healthcare providers, manufacturers, and individual consumers by enabling:

• Faster discovery of flawed medical devices
• Faster recalls
• A reduction in medical errors
• A reduction in counterfeiting
• More informed patient treatment
• A better assessment of device performance
• Improved inventory management
• Doctors to spend more time with patients
• The creation of a world-wide medical device identification system

Faster Discovery of Flawed Medical Devices

When a defective medical device is discovered, it is reported to the Food and Drug Administration (FDA). The FDA receives hundreds of thousands of these reports every year and must determine which are valid, which single-device flaws are, and which constitute a pattern of defects that necessitate a recall.

The medical facilitates submitting these reports are often unsure of when they received the flawed medical device and from which supplier, let alone the manufacture date or batch number. This greatly hampers the FDA’s ability to determine if a reported medical device flaw is a single occurrence or a concerning pattern. 

When a flawed medical device is found, the UDI label will show exactly where the device came from, as well as its batch number and expiration date in some circumstances.

Now when the FDA receives medical device reports, they can cross reference UDI numbers and swiftly identify patterns. In this way, the Unique Device Identification system greatly reduces the timeline between the first flawed device identification and the determination that a recall is necessary.

With UDI, Origen would be able to examine the flawed medical devices and track them back to the manufacturer to more specifically identify when the flaw occurred. If a medical device recall could be pinpointed to specific weeks rather than months or years, it would save massive amounts of time and money and reduce the number of functional medical devices that are thrown out.

Reduction in Medical Errors

By providing specific information regarding device characteristics, the Unique Device Identification barcode makes it easy for healthcare professionals to accurately identify medical devices. This cuts down on time and prevents confusion regarding different medical device models.

Clear USI labeling also allows for an additional level of verification before a medical device is used or implanted in a patient. This extra authentication helps prevent mix-ups, which can have deadly consequences. In some cases, UDI will also ensure that expiration dates are clearly displayed on individual medical devices, instead of only being recorded on the box that the medical devices were shipped in.