On September 24, 2013, FDA published the Unique Device Identification System final rule requiring device manufacturers distributing to the United States to carry UDI compliant labels and submit UDI data to the FDA Global UDI Database. Device manufacturers are given a 5-year rolling schedule to implement starting with the class III at 1-year time frame, class II at 3-year, and class I at 5-year.
Meeting the requirements of UDI means undergoing various process and technology transformations. Device manufacturers need to identify the business impacts, on-board new technology solutions, and transition into the changes. To help device companies sort through the complexity of UDI implementation, LSPediA publishes the UDI Quick Guide that illustrates the steps to achieve UDI compliance. Coupled with the end-to-end UDI service offerings, LSPediA is well positioned as the leader in the industry to help device companies succeed in UDI implementation.