The Food and Drug Administration issued draft guidance clarifying the form and content of special tracking labels for medical devices.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 ...

The Food and Drug Administration (FDA) may be closing in on solving one of its perennial regulatory problems, namely, the absence of a workable regulatory pathway for devices that seek to use older, ...

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 ...