GUDID Journey

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Your Journey to GUDID Submission

Data Submission to GUDID can happen using the GUDID web interface or via M2M using HL7 SPL XML. Labelers with hundreds or thousands of device records may opt to use the M2M option of using GUDID HL7 SPL Submission for more efficiency and reliability. If you decide to use this option, here’s your GUDID journey to compliance using Innovit as a Third-Party Submitter.
Prepare an internal action plan

Prepare an internal action plan/timetable for preparing data for the GUDID depending on the device type and risk class of your devices.

Work with your preferred FDA-accredited issuing agency to assign and maintain UDIs. Currently, the FDA-accredited issuing agencies are GS1, HIBCC and ICCBBA. Identify or obtain your Labeler Dun and Bradstreet (DUNS) numbers.

If your company already has DUNS number(s), verify that the information is current and accurate in the D&B database.

If your company does not have DUNS number(s), obtain one free of charge from D&B. This may take up to 30 business days. Expedited options to obtain a DUNS number are available for a nominal fee.

Gather and validate data required for GUDID

Gather and validate data required for GUDID using Innovit’s GUDID Connector in a Pre-Production environment which provides all the attributes, code lists and business rules based on the GUDID Data Elements Reference Table and HL7 SPL Implementation Specifications and Business Rules.

Request a Pre-Production GUDID Account.

Fill out the GUDID New Account Request form

Fill out the GUDID New Account Request form accurately and identify Innovit as your Third-Party Submitter by providing Innovit’s DUNS number during your GUDID account request. This authorizes Innovit to submit GUDID information on your behalf and will be associated to your labeler account.

Allocate 2-3 weeks for the FDA to provision the Pre-Production Account.

Refer GUDID account setup questions to the FDA UDI Help Desk.

Request an FDA Electronic Submissions Gateway (ESG)

Request an FDA Electronic Submissions Gateway (ESG) Account to submit HL7 SPL files.

Contact the ESG Help Desk for ESG account setup questions.

Allocate 4 weeks for the account to be provisioned.

Complete the GUDID test scenarios

Once ESG and GUDID Pre-Production accounts are established: Use Innovit’s GUDID Connector to complete GUDID testing using the test scenarios specified in GUDID_TestCriteriaProduction.pdf.

Log in to your GUDID Pre-Production Account and verify that your records are submitted correctly.

Send the following Information to the FDA UDI Help Desk for review and production account approval:

For each test scenario:

The CoreID and Primary DI Number. CoreID is assigned by the FDA ESG for each submission and is included in ACK2 and ACK3 messages.

For Scenario 1a, 2a and 3a in GUDID_TestCriteriaProduction.pdf, the GUDID Data Elements that have changed, value before change, and value after change.

The FDA UDI staff will review the information and a GUDID Production Account will be established after a successful review.

Validate, migrate and submit your data

Once GUDID Production accounts are established:

Ensure the data you have gathered and validated is the latest for submitting to GUDID. Migrate the data from Innovit’s GUDID Connector Pre-Production Environment to Production Environment.

If you are migrating from another Third-Party Submitter’s system to Innovit’s GUDID Connector, align Set ID, Core ID and Version ID information for your device records.

Start submitting trusted data to GUDID reliably and efficiently!

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