Methods to Submit Data to the Global UDI Database

Web Interface:
The GUDID Web Interface supports submission, search and retrieval of device information through a secure web interface.  In order to submit device information to the database, you must first obtain a GUDID account.

SPL Submission:
SPL submission allows companies to electronically submit device information one device identification record at a time with an HL7 SPL XML file.  In order submit data using SPL submission, you need to create a GUDID account and use the FDA Electronic Submissions Gateway.  Companies will be required to complete GUDID testing prior to production submissions.

Spreadsheet Uploads:
Some of USDM Life Sciences’ UDI application partners have tools that enable data from spreadsheets to be uploaded to the GUDID.  Contact USDM Life Sciences to learn more about what GUDID submission solution is best for your company.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID.