FDA’S Latest UDI Labeling Requirements

🎤  John E. Lincoln‎         |  📅  July 21, 2023   |  🕒  11 AM Eastern Time US

Areas Covered In The Session: How the New Draft Guidance expands upon the Final Rule.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

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  This New Draft Guidance expands upon the Final Rule and focuses on the two forms of a UDI and clarifies the content of the UDI, including the data delimiters that identify specific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recently released New “Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI) – Draft Guidance for Industry and Food and Drug Administration Staff,”.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

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.