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U.S. Food and Drug Administration
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  2. Medical Devices
  3. Device Advice: Comprehensive Regulatory Assistance
  4. Unique Device Identification System (UDI System)
  5. Global Unique Device Identification Database (GUDID)
  6. Submit Data to GUDID
  1. Global Unique Device Identification Database (GUDID)

Submit Data to GUDID

Before you begin
Device labelers must complete all steps in Prepare for GUDID and then Request a GUDID Account before they submit GUDID data.

The FDA provides device labelers with two options for submitting GUDID data:

  • Manual data entry using the GUDID web application: For submitting single device identifier (DI) records manually through GUDID web application online.
  • HL7 SPL file submission using FDA Electronic Submissions Gateway: For submitting DI records in XML files that comply with Health Level 7 (HL7) Structured Product Labeling (SPL).

Tip: How to Select the Best Option for Submitting GUDID Data

GUDID web application
  • Best if you have a few records to submit to GUDID
  • Easy to use
  • Requires manual data entry
HL7 SPL File Submission
  • Best if you have many records to submit to GUDID
  • Allows bulk submission
  • Requires some technical knowledge
  • Important to retain and organize record submission files

The following graphs from April 2019 illustrate differences in the percentage of labelers using the two options by the number of records submitted as well as the percentage of submissions using the two options.

Percent of labelers submitting GUDID records via Web App vs. HL7 SPL. The graph shows that as labelers submit larger numbers of records, they make increased use of the HL7 SPL option as well as both options

Based on Number of Records Submitted from May 2014 through April 2019

Graph depicting percent of GUDID Records Submitted via Web App (33%) vs HL7 SPL (67%)

Based on Number of Records Submitted from May 2014 through April 2019

Option 1: Using the GUDID Web Application to Submit Data Online

The GUDID web application is an online application for submitting GUDID data.

Image of the log-in page for the GUDID Global Unique Device Identification Database. The page includes fields for Username and Password and a Login button as well as the System User Agreement for accessing a U.S. Government Information System.

Before you use the GUDID web application, read these user manuals:

These manuals provide step-by-step technical instructions and illustrations for using the GUDID web application to submit data.

Log In to GUDID

Option 2: Using the FDA Electronic Submissions Gateway to Submit HL7 SPL Files in XML Format

This option enables companies to electronically submit device information one DI record at a time in an XML file that complies with Health Level 7 (HL7) Structured Product Labeling (SPL).

  • Health Level 7 (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 an HL7 standard for the exchange of product information using extensible markup language (XML). For GUDID, the FDA uses the HL7 SPL Release 5, Draft Standard for Trial Use (DSTU), to receive device identification information.

To use this option:

  1. Follow the instructions in Prepare for GUDID and then Request a GUDID Account to establish GUDID and FDA Electronic Submissions Gateway accounts.
  2. After the accounts are established, complete GUDID testing prior to submitting GUDID data. The HL7 SPL Implementation Files provide detailed information on the testing requirements and process. The files have been updated to include GUDID v1.2.3 HL7 SPL Production release information.
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