Unique Device Identifiers (UDI): Are You Ready?
FDA has mandated a unique device identification system to mark and identify medical devices through their distribution and use. When fully implemented, the label of most devices will include a unique device identifier (UDI) in human- and machine-readable form. By September 24, 2016, the labels and packages of all Class II medical devices must bear a Unique Device Identifier (UDI) and data for such devices must be submitted to the FDA’s Global Unique Device Identification Database (GUDID). In addition, Class III devices that are intended for reuse must bear a UDI as a permanent marking on the device itself.
Just last month, the FDA issued new draft guidance to help define the expected content and forms of the Unique Device Identifier (UDI), to assist both medical device labelers and FDA-accredited issuing agencies in ensuring that UDIs are in compliance with the UDI Rule. And recent industry surveys suggest that UDI compliance and readiness among medical device manufacturers nationwide is low. With UDI deadlines looming, it is clear that OEMs and contract manufacturers have a lot of unanswered questions and challenges with UDI implementation.
Whether you are in the final stages of UDI implementation or just getting started, this session is for you. This session will provide practical insights on just launching – or the final execution – of your UDI compliance plan; and will review some of the common pitfalls and challenges encountered during implementation.
Matt Dryden, Esq., Director QA/RA Consulting, UDI Lead
Mr. Dryden is supporting the QA/RA activities with particular emphasis on implementation of FDA’s Unique Device Identification (UDI) initiative, which requires all Class II device manufacturers to be complaint by September 24, 2016. He also assists with FDA Establishment registration, Device Listing, and US Agent requirements and in 510(k) support activities. He has a BA from Purdue University, West Lafayette, IN, and a JD from Florida Coastal School of Law, Jacksonville, FL. He received certifications for: Core Concepts in Bio-manufacturing and Quality Systems: Applications of cGMPs University of Florida; and Auditing Quality Management Systems certification. Mr. Dryden is a member of the Florida Bar, American Bar Association, and has been admitted to the District of Columbia Bar.
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