FDA GUDID & UDI Compliance for Medical Devices

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The FDA has introduced the Unique Device Identification (UDI) system to uniquely identify and track medical devices marketed in the United States. Under the FDA final UDI rule, device labelers—typically manufacturers or brand owners—must place a UDI on device labels and packaging.

As of September 24, 2022, the FDA requires labelers of all Class I, II, and III medical devices marketed in the U.S. to submit device information to the FDA Global Unique Device Identification Database (GUDID) and obtain a UDI. The FDA system also provides for limited UDI exceptions and alternatives.

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 label 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?

We support medical device companies with reliable UDI and GUDID execution across 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)

Do I need to keep the FDA Food Facility registration number in all communications and invoice?

U.S. FDA requires ﬁlling of Prior Notice before food shipments enter the United States. This will include Prior Notice for food samples for trade shows or consumption. After ﬁlling the Prior Notice, you will be assigned with a conﬁrmation number that will be used by your U.S. customs broker for the shipment release. A Prior Notice can also be ﬁled by your own compnay or international transit ﬁrms as well as shipment companies (DHL, FedEx, TNT, etc).

Do I need to keep the FDA Food Facility registration number in all communications and invoice?

Frequently Asked Questions (FAQ)

Service Details & Fees

GUDID Account

395 USD

UDI Submission

195 USD

Time Required

4-6 Days

30-Min Expert Consultation

Discount on Multiple UDIs