GUDID Account Request: 

Preparation and Process

January 27, 2016

Chris Diamant

UDI Program Analyst

Office of Surveillance and Biometrics

Center for Devices and Radiological Health

U.S. Food and Drug Administration
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The GUDID

• Data submission required by UDI System Final Rule

• Submission must be made to the Global Unique Device 

Identification Database (GUDID)

• Data submission requires establishing a GUDID Account 

• Request account at: 

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/

UniqueDeviceIdentification/GlobalUDIDatabaseGUDID/ucm416113.

htm
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Learning Objectives 

• Understand the GUDID Account Request Process

• Prepare the necessary information to open your account

• Evaluate your GUDID submission options

• Understand the functions of the FDA UDI Help Desk 
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GUDID Roles - Entities

• Organization 

– Highest corporate level of company

– Account is registered to this entity

– Entity responsible for meeting data submission requirements

• Labeler 

– Name of company on the label

– Entity responsible for submitting the data to the GUDID

• Third Party Data Submitter

– May submit records on behalf of the labeler 
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GUDID Roles - Users

• Regulatory Contact

– Responsible for GUDID submission requirements

– May be a third party

• Coordinator

– Manages GUDID labeler accounts

• Labeler Data Entry (LDE) User

– Submits required information for each device to the GUDID
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The GUDID Account Request

• Editable PDF document

• Seven Sections

• Labeler Organization

• Regulatory Contact

• GUDID Submission Option

• Premarket Application Number

• Labeler DUNS 

• Coordinator

• Third Party Submitter (optional)
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Labeler Organization Information

• Represents highest corporate level of the organization

• Includes 

• Organization’s Dun & Bradstreet Numbering System (DUNS) 

number (http://www.dnb.com/government/duns-request.html) 

• Name 

• Address 

• GUDID pulls information from DUNS database

• Contact Help Desk if information changes
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Regulatory Contact Information

• Individual responsible for GUDID submission requirements

• May be an employee of the Organization or an authorized 

third party

• Designating a third party requires letter from your 

Organization stating:

– which devices the third party will serve as contact

– how long the third party will serve as contact

– who will notify the FDA if the third party is modified or removed
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GUDID Submission Option

• Two options:

– Web Interface 

– Health Level 7 Structured Product Labeling (HL7 SPL) submission

• Web Interface option 

– Goes directly to production environment. Published records will be publicly 

visible.

• HL7 SPL option 

– Requires testing in pre-production environment. Pre-production records will not 

be publicly visible and do not satisfy UDI requirements.

– Production access will be granted once testing is completed. 

– HL7 SPL accounts include web interface access 
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Web Interface 

• Offers a form-based method for entering required device 

identification information

• Limited to one record per entry

• Requires less technical expertise

• Best option for users with small quantities of records 
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HL7 SPL

• Uses Extensible Markup Language (XML) schema to submit records

• Can publish multiple records simultaneously

• Must submit completed test results with production account request

• Requires separate account through FDA Electronic Submissions 

Gateway (ESG). http://www.fda.gov/esg

• Requires more technical expertise

• Best option for users with large quantities of records

• Labelers may use a third party to submit on their behalf
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FDA Premarket Application Number

• Method for validating labeler eligibility to open an 

account

• May provide: Premarket Approval (PMA), Premarket 

notification [510(k)], de novo classification, Humanitarian 

Device Exemption

• Do not provide FDA listing number

• Only one valid number is necessary to approve an 

account.
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Labeler DUNS Number

• DUNS number of labeler who is responsible for 

submitting GUDID entries

• Used to identify the labeler for a version or model of a 

device

• Each device record must be associated with a labeler 

DUNS

• Labeler company name in DUNS should match what is 

listed on the device label
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Coordinator Information

• Responsible for management of the GUDID account for 

a specified labeler DUNS

• Creates the Labeler Data Entry (LDE) user accounts in 

the GUDID that create and edit DI records

• Coordinator may also be an LDE user

• May be a member of the organization or a third party 

representative
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Third Party Submitter Information

• Entities authorized to submit to the GUDID on behalf of a 

labeler

• Third parties may request pre-production accounts to 

test their services prior to submitting for clients

• Labeler organizations retain all data access capabilities

• Labeler organizations remain responsible for meeting 

data submission requirements
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Steps for Success

• Ensure that all sections are completed

• Third Party Submitter conditionally required

• Confirm accuracy of information in DUNS database for all 

labeler and organization DUNS numbers

• Identify individuals for each GUDID user role

• Verify that your device is part of one of the Classes open to 

GUDID entry

• Configure email accounts to accept responses from 

“@salesforce.com”
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Help Desk

• Located at: 

http://www.fda.gov/MedicalDevices/DeviceRegulationan

dGuidance/UniqueDeviceIdentification/ucm368904.htm

• Primary method to interact with UDI team

• Questions are submitted via website. Submission 

establishes an email correspondence with an assigned 

case number.
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Help Desk Best Practices

• Complete contact information

• Submit a Help Desk inquiry for a single question 

• Keep follow-up questions related to the original in the 

same email thread

• Submit a new Help Desk inquiry for new questions

• Use system generated auto response email to send 

attachments, if necessary

• Ex: use to submit HL7 SPL test results
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Summary

• Data must be submitted to the GUDID to comply with 

UDI rule requirements

• Establish an account to submit data, following defined 

procedures

• Choose best submission method for your needs

• Use the Help Desk for communicating with the UDI team

• All resources can be accessed at: http://www.fda.gov/udi 
Providing Industry Education

1. CDRH Learn – Multi-Media Industry Education

 over 80 modules - videos, audio recordings, power point presentations, software-based 

“how to” modules

 accessible on your portable devices: http://www.fda.gov/Training/CDRHLearn

2. Device Advice – Text-Based Education

 comprehensive regulatory information on premarket and postmarket topics:

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance

3. Division of Industry and Consumer Education (DICE) 

 If you have a question - Email: DICE@fda.hhs.gov 

 Phone: 1(800) 638-2041 or (301) 796-7100 (Live Agents 9am – 12:30 pm; 1-4:30 pm EST)

 Web Homepage: 

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ContactUs-- DivisionofIndustryandConsumerEducation/default.htm 

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