USA Regulatory ServicesThe FDA Global Unique Device Identification Database (GUDID) stores device identification information to support the implementation of Unique Device Identification (UDI) requirements. Medreg provides complete guidance and support to obtain an UDI which is mandatory for GUDID registration.
UDI is composed of two parts: Device Identifier (DI) & Production Identifier(s) (PI). GUDID contains Device Identifiers (DI) only, however GUDID data indicates which PIs are on the device label. For further information on registered GUDID data, you can visit AccessGUDID database.
There are two ways to submit data to GUDID.
Option 1: Using the GUDID Web Application to Submit Data Online.
Option 2: Using the FDA Electronic Submissions Gateway to Submit HL7 SPL Files in XML Format.
The process involves
- UDI Requirements: Determine applicable UDI requirements and obtain UDIs through an FDA-accredited issuing agency, as applicable.
- GUDID Data Preparation: Compile the required Device Identifier (DI) information, including device identification, labelling, and other applicable data elements.
- Account and Identifier Setup: Establish the required GUDID account access and verify applicable business identification information.
- Submission Method Selection: Choose manual data entry through the GUDID web application for individual records or HL7 SPL electronic submission for bulk data, as appropriate.
- Data Submission and Maintenance: Review the accuracy of submitted information and establish procedures for updating GUDID records when required.
MedReg supports you throughout this process, helping organize the required information and navigate applicable FDA UDI and GUDID requirements.
