September 24, 2016, a date fast approaching, is the deadline for Class II medical devices to be compliant with unique device identifier (UDI) regulations. For compliance, device manufacturers have to submit device identifiers (DI) to FDA for inclusion in the GUDID (Global Unique Device Identifier Database). Device labeling documentation planning is key since once the DI is submitted for a device and entered into the GUDID; further, there are rules for editing during a grace period only and companies may find themselves in situations requiring them to have to obtain a new DI for a device. Keep watching for any FDA updates that may post as this deadline approaches.
More details can be found in Michael Mezher’s informative article posted on RAPS. Pearl Pathways has an experienced team ready to help with your UDI compliance planning and execution, contact us here.