TAKE THE FEAR OUT OF UDI COMPLIANCE

    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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