Purpose and Scope of This FAQ
This FAQ is designed for medical device manufacturers, device labelers, regulatory affairs teams, UDI teams, and other stakeholders responsible for FDA UDI and GUDID compliance. It provides practical guidance for organizations preparing, submitting, and maintaining device identification information in GUDID.
This FAQ focuses specifically on GUDID compliance, including labeler responsibilities, UDI requirements, device data, submission methods, record maintenance, and data quality. It does not provide comprehensive guidance on broader FDA medical device requirements, premarket submissions, device listing, quality system requirements, or detailed UDI labeling and direct-marking implementation.
Understanding GUDID and the U.S. UDI System
GUDID stands for the Global Unique Device Identification Database.
It is the FDA-administered database that contains key device identification information submitted by device labelers for medical devices subject to UDI requirements. Each GUDID record is associated with a Device Identifier (DI) and contains information about a specific device version or model.
GUDID supports the FDA’s broader UDI system by creating a standardized database of device identification information.
The UDI system is intended to improve the identification of medical devices throughout distribution and use and support activities such as:
- Device traceability
- Adverse-event reporting
- Recalls and safety communications
- Supply-chain management
- Electronic health information
- Post-market surveillance
A UDI is a unique numeric or alphanumeric code used to identify a medical device.
A UDI generally consists of two components:
- Device Identifier (DI): The fixed portion that identifies the labeler and specific version or model of a device.
- Production Identifier (PI): The variable portion identifying production information such as lot or batch number, serial number, expiration date, manufacturing date, or distinct identification code, where applicable.
GUDID primarily stores the Device Identifier and associated device information.
Individual Production Identifier values, such as the serial number of each individual device or the lot number of every manufactured batch, are not submitted to GUDID. Instead, the record indicates which types of Production Identifiers appear on the device label.
The GUDID submission system itself is used by authorized labelers and submitters.
Publicly releasable GUDID information is made available through AccessGUDID, a searchable database operated by the National Library of Medicine in cooperation with the FDA.
Patients, healthcare providers, hospitals, researchers, manufacturers, and other stakeholders can search AccessGUDID without a GUDID account.
No.
GUDID, Establishment Registration, and Device Listing serve different regulatory purposes.
GUDID contains UDI-related identification information about device versions and models. FDA Establishment Registration identifies applicable establishments, while Device Listing identifies devices associated with registered establishments.
Meeting GUDID requirements does not replace applicable establishment registration or device listing obligations.
Key Takeaway
GUDID is the FDA’s authoritative database for UDI device identification information. It complements, but does not replace, other FDA regulatory systems such as Establishment Registration and Device Listing.
Scope and Compliance Requirements
In general, medical devices distributed in the United States must bear a UDI on their labels and packages and have applicable device information submitted to GUDID unless an exception, alternative, or FDA enforcement policy applies. Requirements were phased in based primarily on device class and device type.
Yes.
The FDA phased in UDI and GUDID requirements based on device risk and type. The original GUDID submission compliance dates were:
| Device Category | GUDID Compliance Date |
|---|---|
| Class III and devices licensed under the PHS Act | September 24, 2014 |
| Implantable, life-supporting, and life-sustaining devices | September 24, 2015 |
| Class II devices | September 24, 2016 |
| Class I and unclassified devices | September 24, 2018 |
For Class I and unclassified devices other than implantable, life-supporting, or life-sustaining devices, the FDA subsequently exercised enforcement discretion and did not intend to enforce GUDID submission requirements before December 8, 2022.
As a result, the phased GUDID implementation schedule has now been completed. However, certain devices may still qualify for an exception, alternative, or FDA enforcement policy. For example, the FDA does not currently intend to enforce GUDID submission requirements for certain Class I devices considered consumer health products.
Yes.
21 CFR 801.30 provides several general exceptions from certain UDI requirements. The FDA can also grant specific exceptions or alternatives under 21 CFR 801.55.
Whether an exception applies depends on the device, packaging configuration, labeling circumstances, and other factors. Manufacturers should document the basis for any applicable exception or alternative.
Generally, Class I devices required to bear a UDI are subject to GUDID submission requirements.
However, the FDA maintains an enforcement policy under which it does not intend to enforce GUDID submission requirements for certain Class I devices considered consumer health products. Manufacturers should determine whether their particular Class I device qualifies under the FDA’s current enforcement policy rather than assuming all Class I devices are exempt.
The FDA’s Class I consumer health product policy applies to certain devices generally sold directly to consumers and for which GUDID information is considered to provide relatively low public-health value.
The policy affects GUDID submission requirements, not necessarily every other UDI requirement applicable to the device. Labelers should evaluate their products against the criteria in the FDA’s current UDI compliance policy guidance.
Yes.
Implantable, life-supporting, and life-sustaining devices were among the earliest devices required to comply with UDI requirements and are excluded from several of the later enforcement policies applicable to lower-risk Class I and unclassified devices.
They can.
Stand-alone software regulated as a medical device is subject to specific UDI requirements. Where applicable, software must provide its UDI in accordance with 21 CFR 801.50. The specific approach depends on how the software is distributed and whether it is packaged or distributed independently.
Key Takeaway
The U.S. UDI rollout is mature, but not every device is treated identically. Labelers should evaluate device classification, intended use, packaging, applicable exceptions, and current FDA enforcement policies to determine the precise UDI and GUDID requirements for each product.
Labeler Responsibilities and UDI Assignment
Under FDA regulations, the labeler is responsible for meeting applicable GUDID submission requirements.
The labeler is generally the person who causes a label to be applied to a device with the intent that the device will be commercially distributed without subsequent replacement or modification of the label. In many cases, the device manufacturer is also the labeler, but this is not always the case.
The manufacturer is often the labeler, but another organization can be the labeler depending on who causes the final commercial label to be applied or modified. Determining the correct labeler is important because GUDID responsibilities attach to the labeler, not simply to whoever physically manufactures the device.
The Device Identifier, or DI, is the mandatory, fixed portion of a UDI.
It identifies:
- The labeler
- The specific version or model of the device.
The DI serves as the primary key for a device record in GUDID.
The labeler obtains and assigns identifiers using the system of an FDA-accredited issuing agency. The identifier must comply with the issuing agency’s applicable standards and FDA UDI requirements.
FDA-accredited issuing agencies include:
- GS1
- Health Industry Business Communications Council (HIBCC)
- International Council for Commonality in Blood Banking Automation (ICCBBA).
Labelers should follow the applicable issuing agency’s rules when creating and maintaining their UDIs.
Generally, yes.
A DI identifies a specific version or model of a device. Different versions or models requiring distinct identification under FDA and issuing-agency rules need separate DIs and corresponding GUDID records.
Applicable device packages generally require their own DIs.
For example, a device supplied individually and the same device supplied in a package containing multiple units can require separate package DIs representing the packaging hierarchy. Shipping containers are excluded from the definition of a device package for UDI purposes.
Yes.
A labeler can authorize a third-party submitter to submit GUDID information on its behalf. However, the labeler remains responsible for satisfying the regulatory requirements, ensuring the accuracy of its information, and confirming that submissions are successfully received and processed by the FDA.
Key Takeaway
GUDID compliance responsibility rests with the device labeler. Even when manufacturers use third-party technology or service providers, they must maintain control over UDI assignment, device data quality, and regulatory accountability.
GUDID Data Requirements
A GUDID Device Identifier record contains standardized information describing the device associated with the DI.
Depending on the device, this can include:
- Primary DI
- Brand name
- Version or model
- Catalog number
- Company name
- Device description
- Package information
- Production Identifier types
- Sterilization information
- Device characteristics
- FDA premarket submission information
- GMDN information
- MRI safety information
- Commercial distribution status
The applicable requirements ultimately depend on the device type and the relationships between individual data elements.
The Primary DI is the Device Identifier for the lowest level of a device’s packaging containing a full UDI. It serves as the primary key for the DI record in GUDID.
A Package DI identifies a particular package configuration containing a defined quantity of a device. Package DIs enable GUDID to represent relationships between different levels of a product’s packaging hierarchy.
The actual PI values are not submitted.
Instead, GUDID captures whether the device label contains particular types of Production Identifiers, such as:
- Lot or batch number
- Serial number
- Expiration date
- Manufacturing date
- Distinct identification code for applicable human cells, tissues, and cellular and tissue-based products.
GUDID uses the Global Medical Device Nomenclature (GMDN) to provide standardized terminology describing medical devices. The FDA updated its final GUDID guidance in December 2024 to reflect changes to GMDN information in GUDID. GMDN Terms are now available without requiring a paid GMDN membership, eliminating the need for the former FDA Preferred Term alternative.
Where applicable, GUDID records include relevant FDA premarket submission information.
This can include identifiers associated with regulatory pathways such as 510(k), PMA, HDE, or other applicable premarket submissions.
Key Takeaway
A GUDID record contains significantly more than a Device Identifier. Sustainable compliance requires manufacturers to govern a structured set of device, packaging, regulatory, and product attributes and validate them against current FDA requirements.
Submitting Data to GUDID
The FDA provides two primary submission methods:
| Submission Method | Typical Use |
|---|---|
| GUDID Web Application | Manual submission of individual DI records |
| HL7 SPL via FDA Electronic Submissions Gateway | Structured submissions for organizations managing larger record volumes |
The web application is generally best suited to organizations with relatively small numbers of records. It allows users to enter individual DI records directly but requires manual data entry and maintenance.
HL7 Structured Product Labeling (SPL) enables device information to be submitted in structured XML files through the FDA Electronic Submissions Gateway (ESG).
For GUDID, the FDA uses HL7 SPL to receive structured device identification information. This method is generally more appropriate for organizations managing larger device portfolios or automated regulatory data processes.
Yes.
The HL7 SPL submission approach supports higher-volume submission processes and allows organizations to transmit multiple DI records through the Electronic Submissions Gateway rather than manually entering each record through the GUDID web application.
Yes.
Organizations using HL7 SPL must establish the applicable FDA Electronic Submissions Gateway and GUDID accounts and complete required GUDID testing before beginning Production submissions. Testing helps ensure that XML structure, transmission processes, business rules, and organization-specific data are handled correctly.
Yes.
Third party solution providers, like Innovit, can support GUDID submissions. The third-party submitter must be appropriately associated with the labeler’s GUDID account. Regardless of the technical model used, the labeler remains responsible for meeting GUDID requirements.
The decision should consider:
- Number of DI records
- Frequency of device-data changes
- Internal technical capabilities
- Existing product or regulatory data systems
- Data-validation requirements
- Desired level of automation
- Need for submission monitoring and auditability.
For manufacturers managing large portfolios, automated machine-to-machine processes can significantly reduce the operational burden of maintaining, validating, and submitting GUDID records.
Key Takeaway
GUDID supports both manual and automated electronic submissions. Manufacturers with significant device portfolios should consider not only initial submission volume but also the ongoing effort required to validate, update, monitor, and maintain records.
Updating and Maintaining GUDID Records
No.
Labelers are responsible for keeping applicable GUDID information current.
Changes to devices, labels, packaging, regulatory information, or commercial distribution status can require updates to an existing record or, in certain circumstances, assignment of a new DI and creation of a new record.
Under 21 CFR 830.330, when information submitted to GUDID changes, the labeler must generally submit the updated information within 10 business days of the change. Labelers therefore need processes for identifying relevant changes and determining whether a GUDID update is required.
Yes.
After initial publication, GUDID provides a 7-calendar-day Grace Period during which most data elements can be edited. After the Grace Period expires, certain fields become locked and can no longer be changed through ordinary editing.
After the Grace Period:
- Editable fields can continue to be updated as appropriate.
- Certain data elements become locked.
- Changes to locked information may require the record to be unlocked for editing through the applicable GUDID process.
Changes that affect device identity can require a new DI rather than simply editing the existing record.
GUDID records are designed to preserve the historical identity and regulatory information associated with devices.
Manufacturers should not treat deletion as the standard mechanism for handling devices that are discontinued or no longer commercially distributed. Instead, applicable record fields should be maintained to accurately reflect the device’s status.
A new DI is required when a change results in a new version or model under applicable FDA and issuing-agency rules.
Changes that can affect the identity of the device must therefore be evaluated before modifying the product or its labeling.
Labelers should use FDA requirements together with their issuing agency’s DI allocation rules to determine whether a new identifier is necessary.
The applicable GUDID information should be updated to reflect the device’s commercial distribution status. Maintaining historical records supports traceability even after new units are no longer being distributed.
Key Takeaway
GUDID compliance continues throughout the device lifecycle. Labelers should have formal change-management processes for determining when records need updating, when locked fields require special handling, and when a product change requires assignment of a new DI.
Data Quality and Sustainable GUDID Compliance
Publicly releasable GUDID information flows into AccessGUDID and can be used by healthcare providers, patients, researchers, hospitals, regulators, and other stakeholders.
Incorrect or incomplete GUDID information can therefore affect the ability to accurately identify devices and undermine the broader benefits of the UDI system.
The FDA continues to emphasize optimization of GUDID data quality and utility.
Common challenges for manufacturers include:
- Device data distributed across multiple source systems
- Missing or inconsistent regulatory attributes
- Incorrect packaging hierarchies
- Duplicate or outdated records
- Managing large numbers of DIs
- Identifying changes requiring GUDID updates
- Coordinating regulatory and product-data ownership
- Monitoring submission errors and status
- Maintaining alignment between GUDID and authoritative source data.
These challenges become more significant as device portfolios and global UDI obligations grow.
Manufacturers operating globally should avoid unnecessarily maintaining completely independent versions of the same underlying device information for every regulatory database.
Core device information can often be governed centrally and then mapped, transformed, augmented, and validated against the specific requirements of GUDID and other regulatory databases.
However, each jurisdiction has its own data model, validation rules, identifiers, and regulatory requirements, so submissions still need jurisdiction-specific controls.
Manufacturers should establish processes to:
- Maintain authoritative device and UDI master data
- Validate data against current GUDID requirements
- Manage packaging hierarchies and DIs
- Monitor product and regulatory changes
- Determine when new DIs are required
- Submit required updates within applicable timelines
- Monitor submission acknowledgments and errors
Maintain appropriate auditability and governance.
Key Takeaway
Mature GUDID compliance is primarily a data-governance challenge. Manufacturers need sustainable processes that keep regulatory device data complete, validated, synchronized with source systems, and updated throughout the product lifecycle.
Conclusion
GUDID is a mature regulatory requirement, but that does not make compliance a one-time exercise. With the original U.S. UDI implementation schedule largely complete, device manufacturers and labelers should focus on maintaining accurate device information, managing product changes, meeting update requirements, and continuously improving GUDID data quality.
Effective compliance starts with clearly identifying the labeler, establishing appropriate UDI-DIs and packaging hierarchies, maintaining trusted device master data, and selecting a submission approach appropriate for the size and complexity of the portfolio. Manufacturers must then ensure that relevant changes are identified, evaluated, and reflected in GUDID throughout the device lifecycle.
For global manufacturers, GUDID should also be considered as part of a broader UDI data-management strategy. Maintaining a trusted foundation of common device data that can be mapped, augmented, validated, and submitted according to each jurisdiction’s requirements can reduce duplicate effort while supporting more scalable compliance across GUDID, EUDAMED, AusUDID, swissdamed, and other UDI databases.
