Frequently Asked Questions (FAQs)
Have Questions?
We know the UDI process can feel complex. Our FAQ section covers the essentials to help you move forward with confidence.
Yes, most Class I, II, and III devices marketed in the U.S. must comply with UDI requirements, with some exceptions.
UDI compliance improves patient safety, facilitates medical device recalls, enhances supply chain visibility, and ensures regulatory compliance with the FDA and international authorities. Non-compliance may result in penalties, product holds, or market access restrictions.
The Global Unique Device Identification Database (GUDID) is the FDA’s public database. Manufacturers are responsible for submitting and maintaining their device information.
Labeling must include both a human-readable and machine-readable (AIDC) form of the UDI. It must follow FDA formatting rules and contain the correct Device Identifier and Production Identifier elements. AYM Consulting Services can audit and guide your labeling process to ensure compliance.
UDI systems are harmonized but have regional differences. We help ensure your labeling and database entries meet both FDA and MDR/IVDR requirements if needed.
We provide end-to-end support, including UDI strategy development, GUDID submissions, labeling compliance and regulatory updates. Our goal is to simplify the process and help your company achieve seamless compliance with FDA requirements.
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Based in Overland Park, Kansas – Serving clients across the U.S. and Latin America