Resources for You
Global UDI Database (GUDID)
- GUDID Basics
- GUDID Guidance
- Request a GUDID Account
- GUDID Web Interface
- GUDID Health Level 7 (HL7) Structured Product Labeling (SPL)
- GUDID System Status
The Global Unique Device Identification Database (GUDID) is a publicly searchable database administered by the FDA that will serve as a reference catalog for every device with an identifier. Under the UDI final rule, the labeler of each medical device labeled with a unique device identifier (UDI) must submit information concerning that device to the GUDID, unless subject to an exception or alternative.
According to the UDI final rule, “The labeler is the person who causes a label to be applied to a device, or who causes the label to be modified, with the intent that the device will be introduced into interstate commerce without any subsequent replacement or modification of the label; in most instances, the labeler would be the device manufacturer, but the labeler may be a specification developer, a single-use device reprocessor, a convenience kit assembler, a repackager, or a relabeler.”
The GUDID contains ONLY the device identifier (DI), which serves as the primary key to obtain device information in the database. Production Identifiers (PI) are not submitted to or stored in the GUDID, but the GUDID will contain production identifier flags to indicate which PI attribute(s) are on the device label.
The GUDID provides two options for submission of device identification information:
- GUDID Web Interface – enables structured input of device information as one DI record at a time.
- HL7 SPL submission – enables submission of device information as xml files
Both submission options require a GUDID account. GUDID device information submission will initially be open only to labelers of currently marketed class III medical devices and devices licensed under the Public Health Service Act (PHS Act).
The public will have access to information contained in the GUDID. There will be two information retrieval options for published DI information:
- Search and retrieval of device information via secure web interface
- System to system search and retrieval via web service (download capability is planned for the future)
The GUDID will be populated with data about devices according to the compliance timeline in the final rule. However, the public GUDID search function is temporarily disabled until a meaningful dataset of DI records has been created. GUDID accounts will NOT be required for search and retrieval of published information.
FDA has issued the complete Global Unique Device Identification Database (GUDID): Guidance for Industry (June 26, 2014). This guidance describes key GUDID concepts such as account management, user roles, the device identifier (DI) module, DI record life-cycle, package configurations, and the two GUDID submission options (web interface and HL7 SPL).
Currently, the FDA is encouraging labelers of class III devices, and devices licensed under the Public Health Service Act, to refer to the guidance to establish accounts and begin submitting necessary data to the GUDID. The FDA is committed to assisting companies to comply with UDI requirements and submit data to the GUDID in a timely and successful manner.
The FDA is also making available, as separate technical documents, two components of the GUDID Guidance. These two files contain technical specifications only that do not describe the agency's interpretation of or policy on a regulatory issue, and the FDA will not publish them as part of the GUDID guidance in the future.
- The section formerly identified as "Appendix B", which summarizes the device attribute information that will populate the GUDID, renamed as "GUDID Data Elements Reference Table (May 7, 2014)" and
- The section formerly identified as "Appendix C", which summarizes the UDI formats accepted by the issuing agencies FDA that has accredited to date, renamed as “UDI Formats by FDA-Accredited Issuing Agency (May 7, 2014)."
If after reading the guidance labelers have questions on establishing a GUDID account and submitting data, they should submit an inquiry to the FDA’s UDI Help Desk.
Labelers required to submit information to the GUDID must first request a GUDID account. GUDID accounts will initially be provided only to labelers of currently marketed class III medical devices and devices licensed under the Public Health Service Act (PHS Act). These labelers are encouraged to obtain a GUDID account as soon as possible to allow adequate time for system compatibility testing and data submission.
The GUDID account identifies the labeler in GUDID and is required regardless of the submission option chosen by the labeler – Web Interface or HL7 SPL xml file option. Note that the GUDID account is not by submission type, i.e., a labeler does not need to have a separate GUDID account for each submission option.
Prior to requesting a GUDID account, labelers are encouraged to:
- Familiarize yourself with the two submission options available – GUDID Web Interface and HL7 SPL xml file submission.
- Identify the DUNS Number(s) to be used to represent your GUDID account.
- If your company does not have a DUNS number(s), you can obtain one free of charge from D&B. Please note that this may take up to 30 business days; please plan accordingly.
- Expedited options to obtain a DUNS number are available for a nominal fee.
- Please visit http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm162544.htm for more information.
- Ensure the organization name and address associated to the DUNS number is correct; if any changes are necessary, please update your information in the D&B DUNS database accordingly before submitting to GUDID.
- Identify individuals for the various user roles in GUDID -- Regulatory Contact, Coordinator(s) and LDE user(s).
- Identify third-party submitters, if applicable.
- Obtain third-party DUNS number after ensuring that they have verified their information in the DUNS database as accurate.
To request a GUDID account:
- Submit a GUDID New Account Inquiry.
- The FDA UDI Help Desk will email you the GUDID Account Request document in a fillable PDF format. If you do not receive an immediate reply in your inbox, please check the spam/junk folder. If the email was sent to your spam/junk folder, please adjust your spam/junk filter to recognize the FDA UDI Help Desk as a contact to ensure you receive future emails.
- Enter the correct information into the document.
- After completing the GUDID Account Request document, reply to the FDA UDI Help Desk email and attach the completed document.
- Upon receipt of the completed document, an FDA Help Desk Analyst will review your request and respond as soon as possible.
- For all technical questions relating to accessing or setting up your GUDID account, please contact the FDA UDI Help Desk.
Please fill in the information below to initiate a GUDID New Account Inquiry.
The GUDID Web Interface enables submission, search and retrieval of device information via a secure web interface.
To submit device information via the GUDID Web Interface, labelers must first obtain a GUDID account.
In order to assist labelers in submitting data to the GUDID, the FDA has created a GUDID User Manual. This document contains step-by-step technical instructions, for submitting data via the GUDID web interface, including screenshots. Please note, the FDA intends to periodically update this document to reflect system changes and enhancements.
The public GUDID search function is temporarily disabled until a meaningful dataset of DI records has been created.
The HL7 SPL Submission option enables companies to electronically submit device information one DI record at a time as an HL7 SPL xml file.
HL7 is a not for profit, American National Standards Institute (ANSI) accredited standards development organization, whose mission is to provide messaging standards for healthcare interoperability, exchange, management, and integration of data that supports clinical patient care and the management, delivery, and evaluation of healthcare services.
Structured Product Labeling (SPL) is a HL7 standard for the exchange of product information using extensible markup language (XML). For GUDID, the FDA will use the HL7 SPL Release 5, Draft Standard for Trial Use (DSTU), to receive device identification information.
Companies that plan to use the HL7 SPL submission option will need to do the following:
- Establish a GUDID account.
- Use the FDA Electronic Submissions Gateway to submit HL7 SPL files.
- Complete ESG account establishment and testing process.
- Once GUDID and ESG accounts are established, companies will be required to complete GUDID testing prior to production submissions. Detailed information on testing requirements/process is provided in the HL7 SPL Implementation Files The files provide information related to the GUDID Release 1.2.1, which will be pushed to the pre-production environment by the end of April 2014 and to the GUDID production environment by the beginning of May 2014.
CDRH will periodically post updates regarding GUDID system status and downtime/unavailability to users. An email notification will also be sent to email subscribers. You can subscribe to receive email notifications here.
CDRH will make every effort to keep the system status up to date on this web page, but there may be occasions when maintenance will be needed on short notice. In addition, GUDID may be intermittently unavailable during weekends due to maintenance of other FDA systems which may impact GUDID. If you experience unavailability during weekends, and there is no posted downtime notification, we ask that you try again after about 15min.
If you find GUDID system down during week days, or for prolonged periods of time during the weekends, and there is no posted downtime here, please report it to the FDA UDI Help Desk
- CDRH Learn with GUDID Overview
- Draft Guidance – Global Unique Device Identification Database (GUDID) - September 24, 2013 (PDF - 2.8MB)
- HL7 SPL Implementation Files (ZIP - 1.5MB)
FDA Webinar: Global Unique Device Identification Database (GUDID) Account Set Up GUDID Data Elements Reference Table - May 7, 2014(XLS - 91KB) UDI Formats by FDA-Accredited Issuing Agency May 7, 2014(DOC - 132KB) GUDID User Manual -- May 2014(PDF - 2.2MB)