FDA's Crowley addresses Unique Device Identification

摘要

The U.S. Food and Drug Administration has provided a detailed description of proposed effective dates for Unique Device Identification (UDI) requirements on its Web site. Should the agency issue its Final Rule on UDI by June, implementation dates will be based on premarket risk class as follows: one year after publication of the final rule for class Ⅲ devices: two years after publication for class Ⅱ implants and life-supporting/life-sustaining devices that are not class Ⅲ; three years for the rest of class Ⅱ; one to five years for class Ⅰ.