FDA GUDID & UDI Compliance for Medical Devices

Q: What is the difference between a Device Identifier (DI) and a Production Identifier (PI)?

Device Identifier (DI): The mandatory, fixed portion of a UDI that identifies the specific model, version, or trade name of a device and is submitted to GUDID. Production Identifier (PI): The conditional, dynamic portion of a UDI that includes lot/batch numbers, serial numbers, expiration dates, or manufacturing dates.

Click the button below to see the service steps in an easy-to-follow graphic format.

Load Infographic Close

The FDA Unique Device Identification (UDI) system helps identify and trace medical devices marketed in the United States. Under FDA UDI requirements, device labelers—typically manufacturers, specification developers, or brand owners—must assign a UDI and include it on applicable device labels and packaging.

Device labelers must submit required device information to the FDA Global Unique Device Identification Database (GUDID), which links the UDI to key product information and supports device identification, recalls, adverse event reporting, and supply chain management.

As of September 24, 2022, FDA requires labelers of Class I, II, and III medical devices marketed in the U.S. to submit applicable device information to GUDID and obtain a UDI, subject to limited exceptions and alternatives. A UDI or GUDID record does not indicate that FDA has approved, cleared, or authorized the device.

What are Key Components of UDI ?

To generate UDIs, device labelers must submit the required device information to GUDID. A UDI is a unique code composed of a Device Identifier (DI) and a Production Identifier (PI), presented in both human-readable and machine-readable formats.

The DI is the mandatory, fixed portion issued by an FDA-accredited issuing agency and identifies the labeler and the specific device version or model.
The PI is the variable portion and may include production- or device-specific information, such as manufacturing date, expiration date, serial number, lot, or batch number, to support traceability and database searches.

What are UDI submission steps ?

1) Obtain the DUNS number & validate labeler information
2) Assign regulatory contact & request GUDID access (web or ESG)
3) Verify device attributes (GMDN, DL No., GTIN, 510K, etc.)
4) Submit UDIs & device data on GUDID (web-based or HL7 XML)

GUDID UDI Submission Methods

FDA GUDID supports both manual and electronic submission methods, depending on submission volume and internal processes.

GUDID Web Interface – Manual, record-by-record data entry through the FDA GUDID portal. This method is typically used for low submission volumes and requires direct entry and maintenance of Device Identifier (DI) data within the system.

HL7 SPL XML Submission – Structured XML-based submissions transmitted through the FDA Electronic Submissions Gateway (ESG). This method is intended for structured, repeatable, and bulk UDI submissions and requires preparing FDA-compliant HL7 SPL XML files, completing GUDID testing prior to production use, and submitting through an authorized ESG account. HL7 SPL submissions undergo FDA technical and business rule validation, and only accepted records are published to GUDID.

How to place the UDI on a device label?

The device labeling may display the term “UDI” near the code. The UDI is typically presented in two formats: a human-readable identifier and a machine-readable barcode. The example below illustrates a sample device label showing how a UDI may appear.

AccessGUDID & Public UDI Data

The FDA administers the Global Unique Device Identification Database, or Access-GUDID, an extensive catalog for all devices featuring a unique device identifier (UDI). GUDID exclusively contains the device identifier (DI) portion of the UDI and serves as the primary means of accessing device information in the database. Although GUDID does not store Production Identifiers (PIs), it includes PI flags indicating which PI attributes are present in the UDI. The AccessGUDID database also includes the applicable GMDN code and its status, such as Active or Obsolete.

How FDA Listing Inc. can assist?

In addition to FDA medical device establishment registrations, we support medical device companies with reliable UDI and GUDID execution throughout the full submission lifecycle, including both web-based and HL7 SPL XML submission models. Our support includes:

End-to-end GUDID lifecycle management – Support for initial submissions, updates, and ongoing maintenance as device or labeling information changes.
Web-based and HL7 SPL XML expertise – Practical experience with manual GUDID entry as well as FDA-compliant HL7 SPL XML submissions through ESG.
Data quality and submission reliability – Focus on accuracy, validation readiness, and consistent acceptance of GUDID records. This approach reduces errors, saves time, and ensures your UDI submissions are compliant and fully operational.

Please feel free to call or email us if you want to start a conversation.

Service Details & Fees

395 USD

195 USD

4-6 Days

_______ Related Services _______

Frequently Asked Questions (FAQ)

What is a Unique Device Identifier (UDI), and who is responsible for assigning it?

A UDI is a unique numeric or alphanumeric code composed of a Device Identifier (DI) and a Production Identifier (PI). The device labeler (typically the manufacturer or brand owner) requests UDIs through an FDA-accredited issuing agency.

What is GUDID, and why must medical device data be submitted to it?

The Global Unique Device Identification Database is an FDA-managed public database that serves as a central catalog of device identification data. Labelers submit static device data to GUDID so healthcare providers and the public can verify product attributes and traceability.

What is the difference between a Device Identifier (DI) and a Production Identifier (PI)?

Device Identifier (DI): The mandatory, fixed portion of a UDI that identifies the specific model, version, or trade name of a device and is submitted to GUDID.
Production Identifier (PI): The conditional, dynamic portion of a UDI that includes lot/batch numbers, serial numbers, expiration dates, or manufacturing dates.

How are UDI data records submitted to the FDA GUDID database?

Data can be submitted manually through the online GUDID Web Application for low-volume entries, or in bulk using Health Level 7 Structured Product Labeling (HL7 SPL) XML format via the FDA Electronic Submissions Gateway (ESG).

Are all medical devices required to have a UDI and a GUDID submission?

Most Class II and Class III medical devices require a UDI and GUDID entry, but certain Class I items, single-use devices, custom devices, and specific retail consumer products are exempt from GUDID requirements.

When must a company update or resubmit a GUDID record?

You must update GUDID whenever a primary device attribute changes (such as brand name, package size, or sterilizing method) or when a product is discontinued from commercial distribution. Significant modifications to a device’s design or indication often require issuing an entirely new DI record.