In advance of the September compliance date for Class II medical devices, the Food and Drug Administration has issued draft guidance on the form and content of Unique Device Identifiers (UDIs). Though ...
The Food and Drug Administration issued draft guidance clarifying the form and content of special tracking labels for medical devices.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 ...
Channeling Johnny Nash and the 1972 classic song, “I Can See Clearly Now,” on July 7, 2021, the Food and Drug Administration issued its final guidance titled, “Unique Device Identification System: ...
The FDA is in the process of implementing the Unique Device Identification (UDI) System in a series of phases. Currently, all Class III and implantable, life-supporting and life-sustaining medical ...