Unique Device Identification (UDI): Final Rules, Implementation and Compliance

Event Information
Product Format
Prerecorded Event
Dr. David Lim, Ph.D., RAC, ASQ-CQA
60 Minutes
Product Description

Know the Nuts and Bolts of UDI Final Rules: Technical Requirements and Changes Made

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.

Join Dr. David Lim, Ph.D., RAC, ASQ-CQA in this session to understand and implement good practices compliant with the Unique Device Identification (UDI) final rules, which is finally issued on September 24, 2013. David will help you effectively implement a unique device identification (UDI) system applicable to your device types. He will discuss the new changes in the final rules, helping you save enormous amount of time, efforts and resources to achieve compliance and to remain compliant with the final UDI system requirements.

David will also present the good practices of implementing the relevant and applicable UDI system requirements in a CAC-SI manner.

Areas Covered in the Session

  • Applicable Statute(s), Regulations and 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)
  • Impact of the Final Rules to Many Business Areas/Processes
  • Changes in Device Design, Documentation and Manufacturing Processes
  • Good Practices: Practical, Actionable, and Sustainable Strategy
  • Conclusion

Who should attend:

  • R&D
  • Regulatory Affairs
  • Quality
  • Regulatory Compliane
  • Clinical Affairs
  • Consultants
  • Legal and Compliance Officers
  • Marketing Professionals
  • Senior Management
  • Anyone Interested in the Subject

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About Our Speaker

Dr. David Lim - FDA Medical Device  Regulation Expert

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Consulting Firm, Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim frequently presents various topics in areas of FDA regulatory, clinical, quality and regulatory compliance matters in various forums and meetings.

Dr. Lim has helped both pharma and medical device industry for regulatory, clinical and compliance...   More Info
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