Global Unique Device Identification Database (GUDID)
Introduction
The FDA is responsible for ensuring the safety and effectiveness of medical products, including drugs, food, and medical devices. The Unique Device Identification (UDI) system was established under laws passed in 2007 and 2012 to help track medical devices. Device labelers are required to report product details to the Global Unique Device Identification Database (GUDID). This paper gives labelers instructions on how to properly submit data. A recent update removes the use of FDA Preferred Term (PT) codes and requires the use of Global Medical Device Nomenclature (GMDN) codes instead. The FDA will continue improving the database and updating the guidance as needed. Unless otherwise indicated, the recommendations in this text do not impose any legal obligations.
Unique Device Identifier (UDI):
The Unique Device Identifier (UDI) is a code assigned to medical devices to improve tracking, safety, and regulation. It must be created and maintained by device labelers following global standards set by the FDA-accredited issuing agencies (GS1, HIBCC, and ICCBBA). The two components of the UDI are the Device Identifier (DI), a mandatory, which is a fixed code that identifies the device labeler and model and the Production Identifier (PI), a conditional, which can be anything from a batch number to a serial number, expiration date, or manufacturing date. This data is kept in the Global Unique Device Identification Database (GUDID), which makes medical device information accessible to the public, healthcare providers, and regulators. Some exceptions exist for Class 1 devices, which may not require a PI or may be considered compliant if they already have a Universal Product Code (UPC). Before a device is commercially marketed, device labelers are required to provide GUDID with accurate DI information in order to maintain consistency between product records and regulatory filings.
Global Unique Device Identification Database (GUDID)
The Global Unique Device Identification Database (GUDID) is a system that stores key information about medical devices. It only contains the Device Identifier (DI), which is the primary key to finding device details. At the same time, Production Identifiers (PIs) (like lot numbers or serial numbers) are not stored but are flagged if present on the device label. The database makes sure that the data entered corresponds to what is on device labels and complies with FDA rules (21 CFR 830.310). GUDID offers two methods for submitting data: electronically using the HL7 SPL format for large-volume submissions, or manually through a web interface for small-scale users. It also follows standardized naming conventions, including Global Medical Device Nomenclature (GMDN) codes and FDA product codes, ensuring consistency. The information in GUDID is publicly accessible for free, allowing users to search and download device information easily.
A. GUDID Key Concepts:
1. GUDID Account and User Roles: Structure, Management, and Submission Process
The Global Unique Device Identification Database (GUDID) requires medical device labelers to create an account before submitting device information. A GUDID account is necessary to manage device data and identify labelers. The system uses a DUNS (Data Universal Numbering System) number, a unique identification number assigned to businesses and organizations by Dun & Bradstreet (D&B), to track labelers and ensure accurate company details. Every GUDID account has a unique Organization DUNS Number associated with it. Labelers must ensure their company information in the D&B DUNS database matches the details submitted to GUDID.
Each account includes different user roles for managing device data. Although they do not have direct access to the system, a regulatory contact is the main point of contact with the FDA. Coordinators manage the GUDID account, create users, and ensure data accuracy, while Labeler Data Entry (LDE) users handle data submission. Third-party submitters can also be authorized to assist in submitting device data, but labelers remain responsible for the accuracy of the information. Submissions can be made through two methods: manual entry via the GUDID Web Interface (for smaller-scale users) or electronic submission using HL7 SPL XML files via the FDA Electronic Submissions Gateway (ESG) (for high-volume users). Every labeler must first create a GUDID account to submit data via either technique, regardless of the submission mechanism. GUDID information can be searched and retrieved without a GUDID account.
a. Steps to Take Before Requesting a GUDID Account
Before applying for a Global Unique Device Identification Database (GUDID) account, labeler organizations should complete several key steps. They must first select a submission method, such as the HL7 SPL XML file submission (for bulk uploads) or the GUDID Web Interface (for manual entry). Before applying, they must confirm that the company name and address are correct and receive a DUNS number from D&B if they do not already have one. Organizations should then assign user roles, such as Coordinator(s), LDE user(s), and Regulatory Contact. One individual may assume more than one position. If a third party will serve as the Regulatory Contact, they must notify the FDA with an official letter. hey should also designate a person to oversee account modifications and track down any third-party submitters, making sure their DUNS data is accurate. A seamless GUDID account registration process is ensured by completing these steps.
b. Submitting a GUDID Account Request
Organizations can use the FDA website to submit a GUDID account request after all necessary information is available. The submission should include details like the Labeler Organization’s DUNS number, company name, and Regulatory Contact information (name, email, phone, address). Additionally, they have to indicate whether they prefer to submit using the Web Interface or HL7 SPL. Before being granted complete access to the system, HL7 SPL users must finish a testing phase.
After submission, the FDA reviews the request and may ask for clarifications, such as inconsistencies in company details. Once approved, the Coordinator receives login credentials via email and can begin setting up users. There must be a minimum of one Coordinator, one Labeler DUNS number, and one Regulatory Contact per account. To access GUDID, users are given temporary login credentials.
c. Making Changes to a GUDID Account
Organizations must get in touch with the FDA UDI Help Desk to update account information. Changes may include updating Regulatory Contact details, adding new Coordinators, modifying Labeler DUNS assignments, and adding third-party submitters. To prevent problems with Device Identifier (DI) records, a company must notify the FDA beforehand if it is going through a merger or acquisition. In order to efficiently manage business changes, the FDA is continuously working to improve the system.
By taking these actions, companies may make sure that their GUDID accounts are correctly created, maintained, and updated in order to adhere to FDA guidelines and preserve correct device data.
2. Device Identifier (DI) Record
The Global Unique Device Identification Database (GUDID) is a system used to track medical devices through their Device Identifier (DI) Records. Each medical device version or model is assigned a Primary DI, which serves as its main identification number, ensuring that every device is uniquely recorded. Additional identifiers, such as Secondary DI, Unit of Use DI, Direct Marking DI, Package DI, and Previous DI, help in tracking devices across different packaging levels, manufacturers, and regulatory requirements. The GUDID does not store Production Identifiers (PI) but includes flags indicating which PIs (like lot number or expiration date) are on the label. Once assigned, a DI cannot be reused for another device, even if the original device is no longer sold. The FDA enforces business rules to ensure data accuracy, requiring valid attributes and verifying compliance before accepting a DI record. This system enhances patient safety, supply chain management, and post-market surveillance of medical devices.
a. Package Information in GUDID
Every medical device packaging must have a unique identification according to the Global Unique Device Identification Database (GUDID) in order to guarantee accurate tracking during usage and distribution. A Unique Device Identifier (UDI) is required for each package level, including individual devices, boxes of multiple devices, and cartons holding several boxes, per FDA requirements. Larger package configurations have their own Package DI to denote different packaging levels, whereas the Primary DI indicates the smallest packaging unit, also referred to as the base package. Additional features that aid in efficient device tracking include quantity per package, package type, and status. By keeping precise records of device packaging information, this system guarantees precise identification, enhanced inventory control, and enhanced patient safety.
b. Global Medical Device Nomenclature (GMDN)
This section explains that medical device companies must use special codes called GMDN Terms to register their devices in the FDA’s database (GUDID). These codes help categorize devices globally (e.g., dental tools, lab equipment). Each code has a number, name, and definition. Companies need to sign up (for free) with the GMDN Agency to get these codes. When submitting device info:
Use only active codes (check if old codes are outdated).
Update codes within 10 days if they change or become obsolete.
The FDA doesn’t automatically update codes—companies must do this themselves.
If a device doesn’t fit existing codes, companies must request new ones, which takes time. The codes don’t appear on device labels but are critical for accurate FDA records.
B. GUDID Modules
Device identification submissions via the GUDID can be made using HL7 SPL XML files or a secure web interface, both of which require a GUDID account. However, without an account, anyone can search and obtain published device information.
1. GUDID Web Interface
The Global Unique Device Identification Database (GUDID) Web Interface facilitates manufacturers' and labelers' submission, management, and search of medical device data. It is essential to guarantee adherence to FDA guidelines.
The GUDID Web Interface's main features include:
Establishing GUDID Accounts Login credentials are given to users (LDE users) so they can access the system.
Adding device information to the database by submitting Device Identifier (DI) Records.
Locating public medical device records is the goal of searching for and retrieving device data.
a. GUDID Device Identifier Module
Device records in the GUDID system are created, edited, and managed by Labeler DUNS (LDE users) using the DI Module.
LDE users have the following capabilities:
Create DI Records (device identifiers for monitoring medical devices).
Save, edit, and manage draft DI records.
Review & Validate Records (Ensure Compliance with Business Rules).
Copied and edited both published and unpublished DI records.
Search and retrieve device information (public and LDE users have different access).
Requesting a GUDID Account
The labeler must first create an account to request access to the GUDID system.
Organizational information and user role assignment are part of this process (e.g., Labeler Data Entry [LDE] user).
Timeframe: Depending on how thorough the application is, account approval could take a few business days.
II. Creating a DI Record
The labeler makes a DI record for every medical device when the account has been authorized.
Details: The DI record contains important device data like:
The labeler and device model/version are identified by the Device Identifier (DI), a fixed part.
Variable elements such as lot number, serial number, or expiration date are known as production identifiers (PIs).
Other characteristics include Global Medical Device Nomenclature (GMDN) keywords, FDA product numbers, and device descriptions.
Timeframe: The intricacy of the device data determines how much time is needed.
III. Saving as Draft
Before submitting, the DI record can be reviewed by saving it as a draft.
Details: Before validation, this permits an infinite number of updates to guarantee data accuracy.
IV. Reviewing and submitting the DI Record
The labeler sends the DI record to GUDID for validation following their assessment of the draft.
Details: The system verifies that the submission conforms with business requirements, including format consistency and data completeness.
Timeline: As soon as the submission is made, validation takes place.
V. Validation of Business Rules
Outcome 1: Successful Validation
The document enters an "Unpublished State," enabling additional revisions before release.
Outcome 2: Validation Failure
When a record contains errors, it must be fixed and submitted again.
Missing fields or improper formatting are frequent mistakes.
Timeline: The speed at which the labeler resolves problems determines whether to correct and resubmit.
VI. Unpublished State
Until the record is prepared for publishing, unrestricted modifications are permitted in this state.
Details: In response to internal evaluations or regulatory input, labelers may update or improve certain details.
VII. Publishing the DI Record
The DI record is published in GUDID after it has been finalized.
Details:
The public can view published records using the FDA's Access GUDID portal.
After publication, there is a brief "grace period" (usually 30 days) during which edits are permitted.
Only restricted modifications (such as fixing small mistakes) are allowed beyond the grace period.
VIII. Post-Publication Updates
Any revisions made after publication must adhere to FDA regulations for preserving correct device information for the course of the device's lifecycle.
Details: It could be necessary to create a fresh DI record for significant modifications.
Timelines Overview
It takes a few business days to request a GUDID account, depending on how detailed the application is.
The process of creating and reviewing a DI record varies based on the complexity of the device.
Corrections are dependent on the labeler's response time; validation occurs immediately upon submission.
Edits have a grace period of 30 days after publication.
2. HL7 SPL Submission
Device information can be electronically submitted by businesses using the FDA Electronic Submissions Gateway (ESG) as XML files with the HL7 SPL Submission option. Businesses must set up ESG and GUDID accounts, finish testing, and follow the technical requirements in the GUDID HL7 SPL Implementation Files. Although labelers can get help from third-party submitters, they still need to finish test scenarios before submitting to production.
3. Search/Retrieval of Device Information
The public can access GUDID data via the OpenFDA and AccessGUDID portals. These portals offer thorough gadget information, omitting private details like FDA listing numbers and business physical addresses. To guarantee openness and security in the use of medical devices, the general public, including consumers and healthcare professionals, can look up device details.
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