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TAKE THE FEAR OUT OF UDI COMPLIANCE
 
UDI Compliance Guide
READ THE UDI COMPLIANCE GUIDE

Meeting compliance requirements for the FDA Unique Device Identification (UDI) rule is priority-one for today’s medical device manufacturers and labelers. The pressure to meet this demand can be daunting, and available UDI documentation from issuing agencies (GS1, HIBCC) can also be a formidable challenge to the new UDI adopter. This whitepaper offers guidelines for simplifying each step toward UDI compliance and answers common questions about the UDI rule, such as:

►  What is Unique Device Identification?
►  Who is required to participate?
►  How do I register with the FDA and GUDID?
►  What is the timeline to become compliant?
►  What are the different classes of devices and requirements?

 
 


 
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