HL7 SPL Submission Option

March 10, 2016

Linda Sigg

Associate Director of Informatics

Informatics Staff

Office of Surveillance and Biometrics

Center for Devices and Radiological Health

U.S. Food and Drug Administration
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Learning Objectives 

• Obtain an overview of the GUDID HL7 SPL Submission option

• Understand the required testing and process steps

• Learn about the FDA Electronic Submissions Gateway (ESG)

• Identify and understand the three acknowledgements you’ll 

receive

• Learn key pointers regarding editing GUDID HL7 SPL 

submissions

• Understand who and when to contact for help
GUDID HL7 SPL Submission Option

Definitions: 

HL7 = Health Level 7

SPL = Structured Product Labeling

• Submission of medical device information as HL7 SPL 

XML message file

 One DI record per XML file

• Technical specifications available on the UDI website

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GUDID HL7 SPL Submission Option

• HL7 SPL XML submissions sent via the FDA 

Electronic Submissions Gateway (ESG) 

• Testing required prior to production submission

• Suitable for labelers with large volume of 

submissions

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FDA Electronic Submissions Gateway

• Enables secure receipt and authentication of 

FDA electronic regulatory submissions

• Routes submissions to the appropriate Center

– Only one ESG account is needed for all submissions to all 

Centers

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FDA Electronic Submissions Gateway

• Two Options for submission

 WebTrader - use for Low Volume

 AS2 – use for High Volume

• If you choose WebTrader: 

 use GUDID Web Interface, instead of HL7 SPL submissions

• GUDID does not use eSubmitter tool used for CDRH 

eMDR submissions

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FDA Electronic Submissions Gateway

• Acknowledgements for each stage of report 

transmission

• www.fda.gov/esg

• Note Proper Codes

– Center = CDRH

– Submission Type = GUDID

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 Acknowledgements (Ack) 

Labelers 

ESG

CDRH 

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Center = CDRH

Submission Type = GUDID
 Acknowledgements (Ack) 

Labelers 

ESG

CDRH 

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Center = CDRH

Submission Type = GUDID
 Acknowledgements (Ack) 

Labelers 

ESG

CDRH 

Ack1 

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Center = CDRH

Submission Type = GUDID
 Acknowledgements (Ack) 

Labelers 

ESG

CDRH 

Ack1 

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Center = CDRH

Submission Type = GUDID
 Acknowledgements (Ack) 

Labelers 

ESG

CDRH 

Ack1 

Ack2 

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Center = CDRH

Submission Type = GUDID
 Acknowledgements (Ack) 

Labelers 

ESG

CDRH 

Ack1 

Ack2 

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Center = CDRH

Submission Type = GUDID
 Acknowledgements (Ack) 

Labelers 

ESG

CDRH 

Ack1 

Ack2 Ack3 

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Center = CDRH

Submission Type = GUDID
 Acknowledgements (Ack) 

Labelers 

ESG

CDRH 

Ack1 

Ack2 Ack3 

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for Ack1 and Ack2 Issues: contact FDA ESG 

Help Desk, esghelpdesk@fda.hhs.gov

Center = CDRH

Submission Type = GUDID
 Acknowledgements (Ack) 

Labelers 

ESG

CDRH 

Ack1 

Ack2 Ack3 

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for Ack1 and Ack2 Issues: contact FDA ESG 

Help Desk, esghelpdesk@fda.hhs.gov

for Ack3 Issues: contact FDA UDI 

Help Desk, gudidsupport@fda.hhs.gov 

Center = CDRH

Submission Type = GUDID
Acknowledgement Types: Ack1

Ack1/Receipt/MDN

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Acknowledgement Types: Ack1, Ack2

Ack1/Receipt/MDN

Ack2

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Acknowledgement Types: Ack1, Ack2

Ack1/Receipt/MDN

Ack2

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Acknowledgement Types: Ack3

Ack3

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Acknowledgement Types: Ack3

Ack3

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If Ack3 shows <status>failed</status> 
Acknowledgement Types: Ack3

Ack3

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Unidentified: we do not know where to route it

Unparseable: fails validation against the schema

If Ack3 shows <status>failed</status> 
Acknowledgements (Ack) 

Ack3 Issues

• gudidsupport@fda.hhs.gov

• Provide coreID

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Ack1/2 Issues

• esghelpdesk@fda.hhs.gov

• Ack1 – Provide info

• Ack2 – Provide messageID

Contact appropriate Helpdesk regarding issues prior to retransmitting
HL7 SPL Testing Processes

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Request and 

Obtain an 

ESG Account

Complete 

ESG Testing

Request and obtain 

a GUDID Test 

Account

Complete GUDID 

HL7 SPL Testing

Submit Test 

Scenarios for FDA 

Review

Request and 

Obtain a GUDID 

Production Account

Submit DI Records 

to Production 

GUDID

FDA ESG Process

GUDID Process

Time Needed

WebTrader 1-2 weeks

AS2 – 2-4 weeks

Gather Data, 

Generate GUDID 

HL7 SPL XML

Time Needed

6-8 weeks
ESG Testing Process

• Request and Obtain a test ESG account

 Obtain a digital certificate

 Send letter of non-repudiation 

• Complete ESG testing

 Connectivity test

 Load test

• Allocate 2-4 weeks for the above 

• May Use Existing ESG test accounts

• For all GUDID submissions, be sure to specify:

 Center = CDRH

 Submission Type = GUDID

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Request and 

Obtain an 

ESG Account

Complete 

ESG Testing
Generate XML Files

• Build and generate GUDID HL7 SPL XML files

 One file for each DI record

 Validate files against the GUDID schema

• Unparseable error 

 Most common error during GUDID testing from users

 Validating files against the GUDID schema will save you time

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GUDID Testing Process

1. Request a GUDID test account

2. Submit XML files with test scenarios

3. Submit test results to UDI Helpdesk

4. FDA reviews and provides feedback

5. Submit to Production

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Request and obtain 

a GUDID Test 

Account

Complete GUDID 

HL7 SPL Testing

Submit Test 

Scenarios for FDA 

Review

Request and Obtain 

a GUDID 

Production Account

Submit DI Records 

to Production 

GUDID
ESG and GUDID

• ESG serves the entire FDA (all FDA Centers and Programs)

• ESG and GUDID have Test and Production areas

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Submissions sent 

via ESG Test 

Account

Loads to GUDID 

Test System

Submissions sent 

via ESG Production 

Account

Loads to GUDID 

Production 

System
Labelers Using Third-Party Submitters

• Provide Third-Party information during GUDID account request

 If third party is not associated to labeler’s GUDID account, submission 

from third party will be rejected

• Third Parties may:

 Provide software solution/tool to labeler to generate HL7 SPL XML files, 

and then labeler sends submission via ESG

 Labeler obtains ESG account

 Provide end-to-end solution: use labeler data to generate GUDID HL7 

SPL XML files AND send submissions via ESG on behalf of labeler

 Third-party has the ESG account

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Labelers and Third-Party Submitters

• Labelers who intend to use the HL7 SPL submission option: 

 must complete GUDID testing

 even if using a third-party submitter

• Labelers are responsible for fulfilling GUDID submission 

requirements: 

 Ensure submissions received and processed by FDA.

 Login to GUDID and review your submissions

 Report within the required timeframe

 Maintain proper record keeping 30
Third-Party Solution Providers

• May test GUDID HL7 SPL submission solution 

independently of Labelers

 Request a GUDID test Account: indicate it is for HL7 SPL testing

 Dummy data for certain required attributes provided for testing purposes ONLY, 

upon request 

 GUDID Web Interface and Production Accounts NOT provided

• Must complete GUDID HL7 SPL testing with each labeler

 Labelers must establish their own separate test GUDID account

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GUDID HL7 SPL Pointers

• Read FDA Guidance on GUDID

– www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/ 

 GuidanceDocuments/UCM369248.pdf 

• Allow adequate time for testing – ESG and GUDID

• GUDID testing completion criteria is the bare minimum

 Do thorough internal testing to ensure the scenarios appropriate for your products 

are accounted for

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GUDID HL7 SPL Pointers

• Validate submissions against the GUDID HL7 SPL schema

• Do not submit sample message in the HL7 SPL implementation 

package as a test submission – it is not validated

• Specify Proper Fields

– Center = CDRH

– Submission Type = GUDID

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GUDID HL7 SPL Pointers

• Submission folder structure must be followed

 Top level folder must be uniquely named

 Lower level folder must always be named “spl”; only 1 “spl” folder 

 GUDID HL7 SPL xml submission file must be named “submission.xml”

 Do not include any other files in the “spl” folder

 Only one submission (one DI record) in each folder structure
GUDID HL7 SPL Pointers

• Draft DI record state not available in HL7 SPL submission option

• Records can be submitted as

 Unpublished = DI Record Publish Date is in the future

 Published = DI Record Publish Date is today 

 Review your submission via the Web Interface

 Login as a Labeler Data Entry (LDE) user

 Labeler DUNS number for that DI record should be assigned to you

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Data Quality

• Before you move to production

 Complete adequate internal testing 

 Verify test records are loaded correctly to GUDID by logging in

• After you move to production

 Continue to monitor, review and correct records during grace period

 Review information during Grace Period and make edits as needed

 Use “export” feature to export all records in GUDID as XML files

 Remember records go to AccessGUDID after Grace Period

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Data Quality

• Labeler is ultimately responsible for information 

submitted to GUDID 

– it does not matter if third party generates or submits

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Editing HL7 SPL Submissions

• Submit the entire DI record, i.e., include changed and 

unchanged attributes

 DI record will be over-written with the most recent file

 document.setID – links all related submissions

 document.versionNumber – tracks versions; increment by 1 for each 

edit, even for failed submissions

- First time submission, versionNumber = 1, Ack3 = Fail

- Increment versionNumber = 2 before resubmitting

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Editing DI Records

• DI Records submitted using Web Interface

 Draft, Unpublished, Published during Grace Period  must edit via Web 

Interface

 Published and past Grace Period  may edit via Web Interface or HL7 SPL

• DI Records submitted using HL7 SPL

 Any state, any time  may edit via Web Interface or HL7 SPL 

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Submitting Batches in Production

• Start submissions in small batches and slowly ramp up

• Limit submissions to no more than 500 at one time

• If you do not receive Acknowledgements, do not automatically 

“resend”, contact us first

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GUDID System Status

• Scheduled Downtimes

– will be posted on www.fda.gov/udi

– look for GUDID System Status

• Unscheduled Downtimes

o visit www.fda.gov/udi for information

o if no information, report issue via Help Desk

• Subscribe to GUDID Email Alerts

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Summary

• Understand the HL7 SPL Submission Process

• Understand the Testing Requirements for ESG and GUDID

• Understand the edit rules to manage your records correctly 

and accurately

• Understand whom to contact and when for help
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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