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

Event Information
Product Format
Prerecorded Event
90 minutes
Product Description

Update on UDI/GUDID Final Rule, Basic Requirements for Compliance and Impact on Medical Device Manufacturers

 On September 23, 2013, the much anticipated Unique Device Identification System Final Rule was published by the U.S. FDA. It aims to “establish a system to adequately identify devices through distribution and use.” The UDI final rule requires a unique device identifier to be developed in machine readable format and plain text, which is to be a part of the labeling of every medical device.

There is an 4+ year phase in depending upon the risk/class of the device. In addition, the Final Rule will address the four key steps to compliance by device manufacturers and also has provisions to address existing FG inventory, which are not properly labeled.

The Final Rule brings in considerably big changes for medical device manufacturers with far-reaching effects in regulatory compliance, as envisioned by the FDA. It focuses on two core elements and this webinar by expert speaker John E. Lincoln will discuss these two core elements as well as review the implementation schedule of the final rule. John, who has also published an article on UDI/GUDID for an international validation journal, will provide you an in-depth understanding of the Final Rule and what it means for medical device manufacturers.

Session Highlights:

  • Comprehending the Unique Device Identification System Final Rule.
  • Understanding the UDI code, types of acceptable formats, and its use on device labeling.
  • Understanding the FDA-administered Global Unique Device Identification Database (GUDID).
  • Learn the basic requirements of UDI Labeling and its database, GUDID.
  • Review key U.S. FDA publications that address UDI requirements for regulated companies.
  • UDI/GUDID implementation schedules.
  • Required steps for UDI/GUDID compliance by the medical device company.
  • Future requirements.

Who should attend?

  • Senior management in Devices and Combination products
  • QA/RA
  • CROs and Clinicals personnel
  • Medical personnel and Other healthcare professionals, staff and office personnel
  • Consultants; others tasked with product, process, validations, CGMP responsibilities
  • Useful for members of AQC, RAPS, AAMI, etc.

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About Our Speaker

John E. Lincoln

John E. Lincoln is the Principal of J. E. Lincoln and Associates LLC, a consulting company; with over 35 years of experience in U.S. FDA-regulated industries, 21 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation...   More Info
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