Unique Device Identification (UDI): Upcoming FDA Rules, Requirements and Timelines for Industry and Hospitals

Overview:

US-FDA has released a proposed rule (2012) that most medical devices distributed in the United States carry a unique device identifier (UDI). Congress passed legislation in 2007(FDAAA) directing the FDA to develop regulations establishing a UDI system for medical devices.

A UDI system has the potential to improve the quality of information in medical device adverse event reports, which will help to identify product problems more quickly, better target recalls and improve patient safety.
A UDI is a unique numeric or alphanumeric code that includes a device identifier, which is specific to a device model, and a production identifier, which includes the current production information for that specific device, such as the lot or batch number, the serial number and/or expiration date.

The UDI is expected to improve patient safety

• by helping to identify counterfeit products a
• by improving the ability distinguish between devices
• improving the recall process,
• creating efficiencies within the medical system

• Overview and timeline of UDI
• Proposed UDI regulation(FDA, 2012)
• Amendment to the UDI Proposed Rule(2012)
• UDI codes and standards
• Proposed dates for UDI regulations in US
• Benefits of UDI (supply chain, healthcare, industry, public health)
• Post-Market Surveillance & Compliance with UDI
• Lawmakers doubt the release of UDI rule by deadline(2013)
• UDI efforts and recommendations in EU and globally
• Global Harmonization Task Force & International Medical Device Regulators Forum
• Future Of Medical Devices pre- and post- market lifecycle
  

• Medical Compliance Officers
• Health Information Managers
• Legal Counsel, Regulatory affairs
• Data and Device Standards experts
• Health care distributors
• Hospitals and health care providers
• Health care industry professionals
• Healthcare & Devices CIO/CFO/CTO
• Audit/Inspection coordinators, internal auditors
• QA / QC managers, executives and personnel
• Health IT / IS managers and personnel
• Entrepreneurs (Devices, Surveillance, Informatics)
• Consultants and Strategists