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?