UNIQUE DEVICE IDENTIFICATION (UDI): THE LATEST DEVELOPMENTS AND PREPARATION FOR UPCOMING DEADLINES

With the clock ticking on the upcoming September 24, 2014 deadline for Unique Device Identification (UDI) requirements on class III medical devices, manufacturers need to be actively applying resources and building processes to reach UDI compliance. In order to ensure timely and accurate UDI implementation, device manufacturers must submit device data earlier than required to leave time to address any errors and avoid potential hurdles in the submission process.

• Reviewing milestone deadlines
  • Defining FDA UDI exceptions and alternatives
  • Outlining qualifications for deadline extensions
• Preparing for Global Unique Device Identification Database (GUDID) submissions
  • Identifying product with UDI
  • Acquiring and managing required data elements
  • GUDID data submission and maintenance
• Forecasting developments for Class I and II devices

Speaker:
MJ Wylie
Senior Director, Healthcare
GS1 US