Course OverviewPrepare for UDI Implementation
The U.S. FDA UDI Rule establishes a unique device identification system for medical devices. This course is designed for medical device labelers (e.g., manufacturers, repackagers, reprocessors, etc.) or any person involved in implementing U.S. FDA Unique Device Identification (UDI) to help them gain a foundational understanding of specific GS1 Standards that can be used to address certain aspects of the requirements for product identification, product labeling, and submission of information to the GUDID.*
- Course BenefitsGet an overview of the GS1 System, the U.S. FDA UDI Rule, and the GS1 Global Trade Item Number® (GTIN®).
- Course BenefitsGain an understanding of common UDI implementation mistakes and learn how to avoid them.
- Course BenefitsLearn GTIN assignment, packaging hierarchies and allocation, AIDC formats, and the basics of barcoding.
- Course BenefitsGet answers to frequently asked questions for implementation readiness.
Course DetailsGS1 Standards for U.S. FDA UDI
Gain valuable knowledge about how to use GS1 Standards for U.S. FDA UDI requirements that you can bring back to your company and enhance your own professional development.
- LearnThe GS1 Standards that can be used to implement U.S. FDA UDI requirements.
- LearnHow to use GS1 Application Identifiers (AIs) for my Production Identifiers (PIs).
- LearnHow to create properly formatted GS1 Global Trade Item Numbers (GTINs) for use as Device Identifiers (DIs).
- LearnOptions for submitting data to the U.S. FDA GUDID.
Need Help or Have QuestionsContact Us!
Have more questions and would like to speak to one of our course specialists? Please call +1.937.428.3796 (Specialists are available Monday-Friday, 8AM – 5PM ET) or fill out this form and one of our course specialist will get in touch with you shortly.