FDA UDI

The FDA established the unique device identification system to adequately identify medical devices sold in the United States from manufacturing through distribution to patient use.

In general, the UDI final rule requires device labelers (typically, the manufacturer) to:

1. Include a unique device identifier (UDI), issued under an FDA-accredited issuing agency’s UDI system, on device labels, device packages, and in some instances, directly on the device.
2. Submit device information to the Global Unique Device Identification Database (GUDID).

We have 5 years experience of getting medical device product data UDI compliant. We can guide you through the complete process including setting up your GUDID account. Once we have received your data and run quality control checks to make sure it passes the FDA requirements we will submit it to GUDID via an HL7 feed. Our service is ongoing so when you create new products we will submit them on your behalf as well as updating GMDN codes that become obsolete.