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 This New Draft Guidance expands upon the Final Rule and focuses on the two forms of a UDI and clarifies the content of the UDI, including the data delimiters that identify specific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recently released New “Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI) – Draft Guidance for Industry and Food and Drug Administration Staff,”.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- How the New Draft Guidance expands upon the Final Rule.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