By Stewart Eisenhart, Emergo Group
The US Food and Drug Administration has published five new training and education modules on the online platform for the agency’s Unique Device Identification (UDI) program.
Available on the FDA’s CDRH Learn website, the new modules cover areas including:
- An overview of the FDA UDI system and regulations, data and label requirements and implementation schedules
- Preparing a Global Unique Device Identification Database (GUDID) account request and creation
- GUDID Device Identifier Record requirements and submission options
- GUDID HL7 SPL submission options, formats and other requirements
- How to submit data to GUDID using appropriate submission options