The US Food and Drug Administration (FDA) announced Tuesday, 3 July its intent to implement a long-delayed Unique Device Identifier (UDI) rule, which would mandate most medical devices carry an ...

In a highly anticipated move, the US Food and Drug Administration (FDA) has announced the final release of the Unique Device Identification (UDI) rule, reflecting a number of changes called for by ...

The Food and Drug Administration recently released finalized guidance for medical device labelers for submitting data to the Global Unique Device Identification Database. A draft version of the ...

A few short months from now, manufacturers of Class III medical devices must comply with FDA’s unique device identification (UDI) rule. Part 1 of this series focused on the need for companies to start ...

FDA is building a medical device reference catalog through its Global Unique Device Identification Database, which it is opening to the public. Nancy Crotti FDA has opened the Global Unique Device ...