FDA finalizes long-awaited UDI guidance The US Food and Drug Administration (FDA) on Tuesday finalized its guidance on the form and content requirements for unique device identifiers (UDI), nearly ...

FDA has finalized guidance on the form and content of unique device identifiers used to track medtech products through the supply chain. The final text responds to, but in some cases holds firm ...

The Food and Drug Administration issued draft guidance clarifying the form and content of special tracking labels for medical devices. Specifically, unique device identifiers must appear in both plain ...

On January 4, 2016, the Food and Drug Administration (FDA) released a draft guidance intended to clarify the Unique Device Identifier (UDI) labeling requirements for certain medical devices packaged ...

As part of a demonstration project launched via the National Evaluation System for health Technology Coordinating Center (NESTcc), the US Food and Drug Administration (FDA) is considering a national ...

The perceived ambiguity of the US Food and Drug Administration’s (FDA) guidance on Unique Device Identifier (UDI) requirements for combination medical devices could lead to inconsistent implementation ...

The Food and Drug Administration just released a set of new guidance documents to clarify the UDI process for medical device manufacture. Why? Medical devices that are used repeatedly have to be ...

Medical device manufacturers are among the top innovators in the world, developing life-saving technologies at a pace that frequently outstrips that of other industries. Yet when the stakes are ...

One day before the U.S. Food and Drug Administration’s (FDA) deadline for medical device companies to submit Class III product data to the FDA’s Production Global UDI Database (GUDID), GHX announced ...

On September 24, 2013, FDA published its final rule for a system of Unique Device Identification (UDI). The rule has been a few years coming, so industry insiders that had time to get intimate with ...