With phase one of the UDI program in place, medical device companies are either already implementing UDI requirements for class III devices and/or preparing for the next round of implantable, life-supporting and life-sustaining devices labeling and packaging requirements. How this new requirement is affecting packaging professionals as well as how the FDA is dealing with noncompliance is of high concern within the industry. This session will focus on the challenges specifically facing packaging professionals in regards to UDI implementation as well as examine how the FDA is handling noncompliance.
- Lessons learned in deploying UDI requirements within a device company
- Overcoming hurdles in materials and design to ensure UDI compliance
- Recent interactions with FDA when noncompliance is identified
Senior Manager of Labeling, Documentation, and Training