U.S. FDA Unique Device Identifier (UDI) and Global Unique Device Identifier Database (GUDID) Requirements
The U.S. FDA requires medical device labelers to:
- Include Unique Device Identifiers (UDI) on their device labels
- Submit device information to the Global Unique Device Identification Database (GUDID)
- Designate a Regulatory Contact for UDI purposes
Registrar Corp offers simple, low-cost solutions for FDA UDI and GUDID requirements.
For assistance with new FDA UDI and GUDID requirements, simply complete the form below.