New guidance issued by the US Food and Drug Administration (FDA) is intended to clarify the process of "marking" a medical device with a Unique Device Identifier (UDI). Under a final rule released in ...

The US Food and Drug Administration (FDA) is, like many device regulatory bodies around the world, preparing to implement a huge overhaul of its medical device systems. Known as the Unique Device ...

FDA mandates thatthe labeling of alldevices include the manufacturer name, the product name,and the place ofmanufacture and directions for use. As New York Times author Barry Meier recently observed, ...