FDA’s Latest UDI Labeling Requirements

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  This New Draft Guidance expands upon the Final Rule and focuses on the two forms of a UDI and clarifies the content of the UDI, including the data delimiters that identify specific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recently released New “Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI) – Draft Guidance for Industry and Food and Drug Administration Staff,”.

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.

AREAS COVERED IN THE SESSION:

• How the New Draft Guidance expands upon the Final Rule.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.

Course Director: JOHN E. LINCOLN  

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 36 years experience in U.S. FDA-regulated industries, 22 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 and FDA responses, new / changed product 510(k)s, process / product / equipment QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA systems and analysis. He’s held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.