Medical Devices -Implementation of Unique Device Identification (UDI)

Unique Device Identification (UDI) is a new regulation from the U.S. FDA, which requires that the label and device package of each medical device include a UDI. On September 24, 2013, the FDA published a final rule (the UDI Rule), establishing the UDI system. U.S. FDA Code of Federal Regulation (CFR) parts 801.55, 830.10, 830.100, 830.110, 830.120, and 830.130 of the rule came into effect on October 24, 2013; the remaining parts came into effect on December 13, 2013.

As part of the UDI final rule, labelers of medical devices must submit information concerning their devices to the Global Unique Device Identification Database (GUDID). This paper is intended to provide information to the medical device industry concerning the FDA’s UDI system and gives an overview of HCL’s implementation of UDI processes for medical devices and the corresponding business impact.

Medical Devices -Implementation of Unique Device Identification (UDI)