FDA GUDID Excel Template

Save hours of work and remain compliant

FDA GUDID Excel Template

The FDA GUDID template supports you in compiling and managing all the data required by the FDA (Food and Drug Administration).

The template enables you to create convenient solution variants in combination with other products and services from our portfolio.

Please note that a refund is not possible for digital products.

Why use a template?

Device data must be prepared and collated for upload to the FDA’s GUDUD database.

→ To do so, the easiest way is to enter all information in a template with several tabs.

Since we adapt this template to every change and new requirements, you are sure to be compliant and interact in the best way with the FDA.

Included functions:

Template for recording all UDI relevant attributes
Template for capturing additional information such as packaging, storage and handling, and much more
Highlighting of mandatory fields
Easy input with the help of drop-down menus
Designed for easy data transfer to GUDID
Descriptions in German and English

How it works:

What the product looks like:

Frequently answered questions:

Will there be an annual fee for updates?
No.

Will this table help us with our GUDID uploads?
Yes, but not 100%, you still need to convert the data. The conversion to HL7 can be done with our product, the HL7 Converter.

How do I get the most out of the Excel pre-allocation?

That depends on your general conditions. In any case, it makes sense to check whether you can take advantage of another service from our portfolio. You could choose a transfer service where we would take over the transfer of the data to the database for you. In addition, the template in combination with our UDI FDA SAP Add-On offers many other advantages.

Can you say something about the degree of “validation”, or how were the fields restricted and how are dependencies evident?
We have not restricted any fields. We highlight the mandatory and the related applicable fields.