Implementing a Unique Device Identification (UDI) system

Duration: 60 Minutes
This webinar is intended to help you get familiar with the Unique Device Identification (UDI) final rules and adequately implement a UDI system in accordance with the final rules, issued on September 24, 2013.
UDI regulations
Instructor: David Lim
Product ID: 500154
This webinar will discuss new changes in the final rules, helping to save you an enormous amount of time, efforts and resources to achieve compliance and to remain compliant with the final UDI system requirements.

In 2007, Congress passed legislation directing the FDA to develop regulations establishing a unique device identification system for medical devices. The UDI final rules are intended to establish a system to adequately identify devices during use and distribution. According to the finalized UDI rules, most medical devices distributed in the US are required to carry a Unique Device Identifier unless subject to an exception or alternative placement. The UDI system requires each device and each package to carry a UDI, the UDI of which should be provided in a plain text and in a form usable by automatic identification and data capture (AIDC) technology.

If the device is intended to be used more than once and intended to be reprocessed before each use, the UDI must be directly marked on the device itself. The speaker will present how to implement the UDI system requirements in a CAC-SI manner.

Objectives of the Presentation:
  • Applicable Statute(S) and Regulations
  • Definitions
  • UDI Development History
  • UDI Final Rules: Technical Requirements and Changes Made
  • When to Use a UDI and When to Discontinue Its Use
  • UDI System Requirements including Technical Standards
  • Requirements for a Unique Device Identifier
  • FDA Accreditation Process for an Issuing Agency including Suspension and Revocation
  • UDI Rules: Applicability
  • UDI Rules: Exceptions and Alternatives
  • Compliance Dates for the Applicable Requirements Over Seven (7) Years
  • Device Identifier Formats including Dates
  • Global UDI Database (GUDID): Technical Requirements (Data Format and Data Attributes)
  • Understanding Impact of the Final Rules to Many Business Areas/Processes
  • Changes in Device Design, Documentation and Manufacturing Processes
  • Practical, Actionable, and Sustainable Strategy: Good Practices to Adequately Implement a UDI System
  • Speaker’s Practical Tips.
Who can Benefit:
  • Regulatory Affairs
  • R & D Scientists and Engineers
  • Quality
  • Compliance
  • Clinical Affairs
  • Marketing
  • Consultants
  • Legal and Compliance Officers
  • Senior Management
  • Anyone Interested in the Subject
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Instructor Profile:
Dr. David Lim is President and Principal of Regulatory Doctor. Regulatory Doctor provides Practical, Actionable, and Sustainable Solutions in an Integrated, Thorough ("PASS-IT") manner.

Dr. Lim obtained his Ph.D. in biological sciences at the University of Missouri-Columbia and published his thesis research in the prestigious journal "Science." Since then, Dr. Lim has held various positions at Duke, Caltech, US National Laboratories, Intrexon Corporation, Terumo, US FDA/CDRH, and EraGen Biosciences, Inc., A Luminex Company. In 2009, Dr. Lim served as a panel member during the FDA’s Transparency Public Meeting. Prior to founding his own consulting firm (www.RegulatoryDoctor.com), Dr. Lim was Senior Vice President of Scientific and Regulatory Affairs at Aquavit Pharmaceuticals, Inc. in New York. Dr. Lim as Regulatory Doctor provides practical, actionable and strategic solutions integrated with emotional intelligence (EQ) skills for all aspects of global regulatory, quality, clinical and compliance matters.

Over the years, Dr. Lim has analyzed thousands of FDA warning letters including thousands of MDRs. Dr. Lim has also attended more than 50 FDA advisory panel Meetings and analyzed the subject matters and decision-making processes. Dr. Lim is familiar with hundreds of medical products (medical devices including IVD products, biologics, drugs and combination products). Dr. Lim is a certified professional for regulatory affairs (RAC) and also is a certified quality auditor (CQA) by the American Society for Quality (ASQ). Dr. Lim also is a regulatory coach, mentor, consultant and public speaker for global matters pertaining to regulatory affairs, regulatory compliance, quality and clinical affairs. Dr. Lim has been actively engaged in identifying and addressing regulatory hurdles and submission issues including, but not limited to, patient-safety signals and concerns. Dr. Lim co-authored the Regulatory Affairs Professional Society (RAPS)'s online class materials for EU medical device regulations.
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