Establishing an FDA-Compliant UDI System

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This seminar is intended to help you effectively implement a unique device identification (UDI) system based on the final rules issued and published in federal register. Specifically, new changes in the final rules will be discussed, contributing to saving an enormous amount of time, efforts and resources to achieve compliance and to remain compliant with the final UDI system requirements.
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.
In this 60-min presentation, the speaker will guide you through the details of how to implement the UDI system requirements in a CAC-SI manner. You will have opportunities to bring great value and benefits to your firm’s implementation of a UDI system in an efficient and effective manner.

Areas to be Covered:

Applicable Statute(S), Regulations and Enforcement Authority
UDI Development History
UDI Final Rules: Technical Requirements and Changes Made
When to Use a UDI and When to Discontinue Its Use, and When to Use a New UDI
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, Exceptions and Alternatives
Devices at a Retail Store, Delivered to Health Care Facility, Outpatient Treatment Facility, Nursing Home, Ambulatory Surgical Center, and Hospitals
Devices Labeled Prior to Compliance Dates
Devices (Single Use, Custom, Intended for Export, Convenience Kits, Combination Products, Medical Procedure Kits and Trays)
Class I Devices: cGMPs Exempted
When to Request Exceptions and Modifications
Which Devices Not Required to Have a Production Identifier
Direct Marking Requirements and Revised Changes
Requirements for Stand-Alone Software
Compliance Dates for the Applicable Requirements Over 7 Years
Device Identifier Formats including Dates
Global UDI Database (GUDID): Technical Requirements (Data Format and Data Attributes)
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 Implement UDI Systems Fast

Who will Benefit:

R&D Scientists, Managers, Directors, and VPs
Regulatory Affairs and Compliance Professionals
Clinical Affairs Professionals
Quality Professionals
Legal and Compliance Officers
Marketing Professionals
Senior Management
Anyone Interested in the Subject

Dr. David Lim

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor ( As a leading industry speaker, Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings. Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past eight years. Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.

Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker. Dr. Lim leads and directs all research projects including pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Dr. Lim currently serves as a member of the Advisory Board for Inspection Insider published by FDA News.

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  • Presentation Handout in .pdf format
  • Certificate of Attendance