As 2014 fades into memory, the medical device industry faces the next phases of Unique Device Identification (UDI) implementation for devices marketed in the US. September 2015 is the deadline for UDI labeling implementation and data submissions for Implantable, Life-Supporting and Life-Sustaining (I/LS/LS) devices with the remainder of Class II devices following in 2016. 1 The Class III device UDI compliance date passed on 24 September 2014. Overall, implementation of ...

The US Food and Drug Administration (FDA) Unique Device Identification (UDI) final rule, 1 released 24 September 2013, requires medical devices distributed in the US to include a UDI value on the device label and package. The UDI combines a static device identifier, assigned by an FDA-approved issuing agency, and a series of dynamic production identifiers, taken from information on the device’s label. The rule also requires medical device manufacturers to submit ...