PREPARE DEVICE DATA SYSTEMATICALLY
FDA GUDID Excel Template: capture structured UDI data
Bring your device information into a shared structure as the basis for subsequent GUDID submission.
The FDA GUDID Excel Template from Europe IT Consulting helps compile and manage the device data needed for your GUDID process. Multiple worksheets, highlighted fields and selection lists make editing easier. Descriptions in German and English support collaboration between your specialist teams.
The template is a data preparation tool. It is not a direct Excel upload to GUDID or automatic confirmation of FDA compliance. For electronic submission, the data is checked, converted to the appropriate format and transmitted in a separate process.
How the template supports data capture
Shared structure
- Capture UDI-related device attributes.
- Additional information such as packaging, storage and handling.
- Multiple worksheets for related information.
- Descriptions in German and English.
Guidance during data entry
- Highlighting of mandatory fields.
- Identification of conditionally applicable fields.
- Selection lists to assist data entry.
- Preparation for a subsequent conversion and submission process.
This gives Regulatory Affairs, master data owners and IT a shared working basis. The template helps bring information together systematically; it does not replace the substantive review of your product information.
Get a quote for the GUDID template
Please also tell us whether you need only the template or conversion and submission services as well.
Field highlighting is not complete data validation
The existing template highlights mandatory and conditionally applicable fields; according to the product description, fields are not generally restricted. A colour highlight therefore does not mean that a schema or authority check has been passed.
Distinguish three checks: Has a field been completed? Is the information substantively correct? Does the record meet the technical rules of the target process? These questions require different checks.
GUDID uses business rules for individual data attributes. The FDA provides the current reference on its GUDID page with the Data Elements Reference Table . In the agreed submission process, this reference must align with data mapping and technical checks.
If you need automated portal validation, consider the template in conjunction with the Global Submission Portal . This portal check is a separate software function, not a capability attributed to the Excel file.
From completed template to GUDID submission
- Compile device data: map existing information from your sources and complete missing details.
- Review the content: check product identification, packaging information and other applicable attributes.
- Define the conversion route: the file-based GUDID process requires HL7 SPL XML files, not an unchanged Excel workbook.
- Submit and handle feedback: after setting up the agreed process, review the results and make corrections where necessary.
The FDA explains the official submission methods under Submit Data to GUDID. Europe IT supports the subsequent steps according to the agreed product or service scope.
Which addition fits your way of working?
- Portal: GSP for the customer-operated import, validation and submission workflow using the designated module template.
- SAP: GUDI for SAP-based UDI data management and authority submission. Additional Excel maintenance should not be introduced in parallel without a need.
- Project support: discuss data preparation and submission if you need a clearly defined service scope.
Before use, we agree which template version works with which solution and whether additional conversion services are needed. The precise scope of the HL7 Converter mentioned in the existing content must be clarified in the quote.
A look inside the template
The existing product view shows its structure and operation. The template version offered for your project is the applicable one.
Questions about the FDA GUDID Excel template
Can the FDA read my Excel file directly?
The Europe IT template is the working basis for data capture. Conversion follows for file-based GUDID submission. Buying a template alone does not set up automatic submission to an authority.
Is the template published by the FDA?
No. It is a Europe IT Consulting product. Official data requirements and technical documentation come from the FDA.
Is there an annual update fee?
According to the existing product description, there is no annual update fee. We confirm the version, service and update scope applicable to your order in the quote.
Does the template also help with eMDR?
This template is intended for GUDID device data. Electronic incident reporting requires a different dataset and workflow. Find more information on our eMDR page.
Can it automatically convert any Excel list?
Automatic import of arbitrary external formats is not promised for this template. Existing columns and values must fit the intended structure; any necessary mapping is considered separately.
Where can I find the official requirements?
Our FDA/GUDID link collection takes you to the relevant primary sources. To clarify the basic concepts first, start with FDA UDI and GUDID.
Template only or with a submission process?
Tell us your source system and the workflow you need. This allows us to offer the right combination of template, conversion and submission support.
FDA sources checked on . Product images may show an older version.
