Long-Awaited Final UDI Rule Addresses Industry Concerns

After six years and a slew of missed deadlines, the FDA Friday published its final unique device identification (UDI) rule, forever changing how devicemakers label their products. The final rule drew plaudits from industry for addressing concerns surrounding UDI placement and implementation. The agency touted UDIs as a way to ease confusion surrounding recalls and improve adverse event reporting.
Devices & Diagnostics Letter