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 ...
On July 25, 2022, the U.S. Food and Drug Administration (FDA) issued final guidance on Unique Device Identification (UDI) compliance date policies, stating that the agency will not enforce a ...
The US Food and Drug Administration (FDA) issued an updated final guidance on Tuesday addressing the submission of unique device identifiers (UDIs) to the Global Medical Device Nomenclature Database ...
Regulators with the US Food and Drug Administration (FDA) have released a second, substantially more complete guidance document indicating how its Global Unique Device Identification Database (GUDID), ...