Unique Device Identification System

May 2014
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Unique Device Identification System

At a glance

PwC's guidance and analysis on the impact of Unique Device Identification for pharmaceutical manufacturers and medical device industry

PwC’s Unique Device Identification team has significant experience working with organizations at various stages of UDI readiness. Such experience has helped our UDI team compile this view of what’s required for successful UDI programs.

Our report examines the effect of the FDA's Final Rule for Unique Device Identification (UDI) on medical device manufacturers and health care providers. It outlines:

  • Key compliance deadlines and core compliance requirements
  • Challenges facing medical device manufactures
  • Benefits of UDI for health care providers
  • PwC's perspective on successful programs for UDI
  • Outlook moving forward