U.S. FDA Releases New Draft Guidance on UDI Label Form and Content

Event Information
Product Format
Prerecorded Event
Conference Date
Wed, Sep 21, 2016
90 minutes
Product Description

U.S. FDA’s New Draft Guidance on UDI Label Form and Content

The U.S. FDA is well into their long-anticipated Unique Device Identification System. Its purpose is to "establish a system to adequately identify devices through distribution and use". It requires the development of a unique device identifier (UDI) in plain text and machine readable formats, to be part of the labeling of every medical device. This is a multi-year phase in, based on the risk / class of the device.  This New Draft Guidance expands upon the Final Rule and focuses on the two forms of a UDI and clarifies the content of the UDI, including the data delimiters that identify specific data elements within the UDI.

This is a major change for medical device manufacturers, with far-reaching effects in regulatory compliance, as envisioned by the FDA.

This Live Webinar by expert speaker John E. Lincoln, who has also published an article on UDI/GUDID for an international validation journal, will focus on the U.S. FDA’s recently released New “Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI) - Draft Guidance for Industry and Food and Drug Administration Staff,” dated July 25, 2016.

The session discusses the basic requirements of UDI Labeling and its database, GUDID and provides a list of key U.S. FDA publications that address UDI requirements for regulated companies and accredited agencies. It will also provide an overview of UDI / GUDID implementation schedules and discuss the required steps for UDI / GUDID compliance by medical device companies and future issues.

Session Highlights

  • How the New Draft Guidance expands upon the Final Rule.
  • The two forms of a UDI and clarification on the content of the UDI
  • The data delimiters that identify specific data elements within the UDI
  • The order of the data in a UDI and UDI carrier
  • Types of acceptable formats, and its use on device labeling
  • The FDA-administered Global Unique Device Identification Database (GUDID)
  • The Draft’s definition on the expected content and forms of the UDI, for both medical device labelers and the FDA-accredited issuing agencies.
  • How the Draft will better assist compliance with the UDI Final Rule
  • The implementation schedule

Who Should Attend

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

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

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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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