FDA UDI FAQs

The FDA Unique Device Identification system establishes requirements for identifying medical devices throughout distribution and use. For device labelers, those requirements can involve UDI assignment, labeling, direct marking, and submission of device information to the Global Unique Device Identification Database (GUDID). For healthcare organizations, UDI also creates an opportunity to capture standardized device identification data directly from medical device labels and packages.

These FDA UDI FAQs cover the fundamentals of unique device identification, UDI barcodes and data, direct marking, GUDID, and the use of UDI information within healthcare workflows.

The FDA established the Unique Device Identification (UDI) system to provide a consistent way to identify medical devices distributed in the United States from manufacturing through distribution to patient use.  In general, the UDI Rule requires device labelers, typically the manufacturer, to place a unique device identifier on device labels and packages unless an exception or alternative applies. Certain reusable devices that are intended to be reprocessed before each use must also bear a permanent UDI marking on the device itself. Device labelers are also generally responsible for submitting required device information to the FDA's GUDID.
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A unique device identifier is a numeric or alphanumeric code used to identify a medical device. A UDI generally consists of two types of information:

Device Identifier (DI) identifies the labeler and the specific version or model of the device.

Production Identifier (PI) provides variable production information when that information appears on the device label, such as a lot or batch number, serial number, expiration date, manufacturing date, or certain distinct identification codes for qualifying human cells, tissues, and cellular and tissue-based products.

The Device Identifier (DI) is the fixed portion of the UDI. It identifies the labeler and the specific version or model of the medical device.

The Production Identifier (PI) is the variable portion and can include production-specific information such as lot or batch number, serial number, expiration date, manufacturing date, or other applicable information.

This distinction becomes important when UDI data is captured electronically because the receiving workflow may need to identify, validate, parse, and use individual data elements rather than treating the entire barcode as a single text string.

For devices subject to the applicable UDI labeling requirements, the device labeler generally provides the UDI in two forms: easily readable plain text and a machine-readable form using Automatic Identification and Data Capture (AIDC) technology. AIDC allows the UDI or Device Identifier to be entered into an electronic record or computer system through an automated process.

When applicable UDI labeling requirements apply, the UDI must be provided in a form that uses AIDC technology, but the FDA's definition of AIDC is technology-based rather than limited to one particular barcode symbology. In many medical-device workflows, UDI information is encoded in linear or two-dimensional barcodes that can be captured with compatible barcode readers.

The FDA currently recognizes three accredited UDI issuing agencies:
•GS1
•Health Industry Business Communications Council (HIBCC)
•ICCBBA

Each has an FDA-reviewed UDI format.  Device labelers work with an FDA-accredited issuing agency to develop UDIs according to the agency's system.

Yes. Depending on the issuing agency's format and the information required for the device, machine-readable UDI data can contain the Device Identifier along with applicable Production Identifier information.

For a receiving organization, capturing the barcode is therefore only one part of the workflow. The decoded data may need to be validated, separated into relevant elements, formatted appropriately, and passed to the receiving application.
See How BarCodeOS® Processes Barcode Data →

Hospitals can use compatible barcode scanning technology to capture machine-readable UDI information from medical-device labels and packages. The workflow should also account for what happens to the decoded information after capture. Depending on the application, relevant UDI data may need to be validated, parsed, formatted, and passed to the hospital system or workflow that needs it.

ID Integration's BarCodeOS® can perform those data-processing functions within the barcode scanner before the resulting information is transmitted to the host computer.  Explore FDA UDI Barcode Capture →

Yes. Validation rules can be applied to decoded barcode data as part of the capture workflow.

BarCodeOS® can evaluate captured UDI data within the scanner according to configured rules before sending information to the receiving system. Depending on the workflow, this can help identify data that does not meet expected requirements and give staff an opportunity to investigate the barcode or data issue.

Recurring problems can also provide useful information for follow-up with suppliers.

Under the FDA's UDI requirements, a device that is required to bear a UDI on its label generally must also bear a permanent UDI marking on the device itself when the device is intended to be used more than once and intended to be reprocessed before each use, subject to applicable exceptions, alternatives, and FDA compliance policies.  Not every medical device is therefore subject to the same direct-marking requirement.

No. FDA UDI requirements vary based on the device and applicable regulations, and the UDI Rule includes exceptions and alternatives. FDA has also issued compliance policies affecting particular device categories and requirements.  Device labelers should use current FDA regulations and guidance to determine the requirements applicable to a specific device rather than relying on a general FAQ as a compliance determination.  Review FDA UDI requirements →

Not necessarily. FDA specifically notes that implantable devices are not required to bear a direct UDI marking under the direct-marking requirement discussed in its current compliance guidance.  UDI labeling, packaging, GUDID, and other requirements may still apply depending on the device. The direct-marking requirement should be evaluated separately.

The Global Unique Device Identification Database (GUDID) is the FDA-administered database containing identifying information for medical devices with UDIs. Device labelers are generally responsible for submitting required device information to GUDID. The database contains the Device Identifier but does not contain Production Identifier values such as individual serial numbers or lot numbers.

AccessGUDID is the publicly searchable interface for device identification information from GUDID. It is provided through a partnership between FDA and the National Library of Medicine. Healthcare providers, hospitals, patients, industry users, and others can search for devices using information such as device name, company, or Device Identifier.

No. AccessGUDID does not contain information identifying who uses a particular device or other personal patient information.

UDI provides standardized device identification that can be captured and used in electronic healthcare and operational workflows. Depending on the application, captured UDI information can support device identification, inventory and supply-chain workflows, documentation, recalls, registries, and other processes that depend on reliable medical-device data.

The FDA itself describes broader value from integrating UDI into electronic healthcare data sources, including supply-chain systems, electronic health records, and registries.  The value to an individual organization depends on how accurately the data is captured and how effectively it is connected to the workflow and systems that use it.

Yes. Captured UDI information can be parsed and formatted for use by receiving applications when the required system interfaces and workflow are defined. The appropriate integration depends on which UDI data elements the hospital needs, the format expected by the receiving application, when capture occurs, and what the system needs to do with the information.  ID Integration considers the complete workflow from barcode capture through data processing and delivery to the receiving system.

BarCodeOS® extends the capability of barcode reader hardware by using processing within the scanner to act on decoded data before it reaches the host computer. For UDI applications, BarCodeOS can be configured to validate expected data, parse relevant UDI elements, format the output, and pass the resulting information to the receiving hospital application or workflow.  This can move important data-processing functions closer to the point of capture rather than relying on staff to manually interpret or re-enter encoded information.

Explore BarCodeOS® Intelligent Scanners →
Explore FDA UDI Barcode Capture →

Put UDI Data to Work

A UDI barcode contains valuable device information, but the operational value comes from capturing the data accurately and getting the right information into the systems and workflows that need it. ID Integration can help design the barcode capture, validation, parsing, formatting, and system connections required to turn UDI data into usable information.

FDA UDI Barcode Capture → See how UDI data can be captured and processed at the scanner

BarCodeOS® Intelligent Scanners → Explore embedded barcode data processing

Medical Device Manufacturers → Explore solutions for medical-device identification and workflow requirements