…the latest news you should know
Unique Device Identification (UDI) requirements for medical devices are currently being implemented by the FDA. Class III devices have had requirements in place as of Sept 2014. Many devices (most Class II) have upcoming deadlines in Sept 2015. The FDA announced last year it would delay Class II direct marking requirements but Global UDI Database (GUDID) and label requirements are still in place for later this year.As many companies are scrambling to learn what all of this means and how it affects their quality system and logistics, Kapstone is staying on top of the latest UDI news to better serve our customers.