Implementing a Unique Device Identification (UDI) System - Issued on September 24, 2013 2014

Key Topics

• Definitions
• Statute(s) and Regulations
• UDI Final Rules: Technical Requirements and Changes Made
• UDI History
• UDI System Requirements including Technical Standards
• When to Use a UDI and When to Discontinue Its Use
• FDA Accreditation Process for an Issuing Agency including Suspension and Revocation
• Requirements for a Unique Device Identifier
• UDI Rules: Exceptions and Alternatives
• UDI Rules: Applicability
• Device Identifier Formats including Dates
• Compliance Dates for the Applicable Requirements Over Seven (7) Years
• Impact of the Final Rules to Many Business Areas/Processes
• Global UDI Database (GUDID): Technical Requirements (Data Format and Data Attributes)
• Good Practices: Practical, Actionable, and Sustainable Solutions/Strategy
• Changes in Device Design, Documentation and Manufacturing Processes

Who should Attend

• Regulatory Affairs
• R&D
• Regulatory Compliance
• Quality
• Consultants
• Clinical Affairs
• Marketing Professionals
• Legal and Compliance Officers
• Senior Management