Join us for a detailed walk-through of the US FDA Class I medical device category and requirements for Unique Device Identification (UDI).
Is your organization manufacturing devices classified as ‘class I’? Class I devices and devices that have not been classified into class I, class II or class III that are required to be labeled with a UDI code, must submit product data to the FDA’s GUDID by September 24, 2022 (moved from September 24, 2020). FDA announced a two-year shift of the enforcement of this compliance date on June 30, 2020.
Based on your manufacturing scenario, you may be required to submit specific product data to US FDA by September 2022. Join us for a detailed walk-through of the US FDA Class I medical device category and requirements for Unique Device Identification (UDI).
• UDI definition and goals
• FDA UDI Requirements
• Label Data vs. GUDID submission data
• UDI Class I Exceptions
• FDA GUDID Compliance: Submission/Maintenance
• Planning your scenario-based UDI data strategy
• How Reed Tech can help
Bring your questions. We will also provide a table of the required data attributes and other key takeaways in the slides. Getting an early start is advisable as we start the new year. UDI preparation can be complex and time-consuming without subject-matter expertise.
For regulatory teams working on US FDA class I data, this webinar will be a helpful walk-through of the main takeaways in the published information from the FDA and experienced guidance from the UDI ‘go-to’ specialists
Who Should Attend
• Regulatory Affairs/Operation Leaders
• Product Managers and Business Analysts
• Manufacturing, Operations, and Supply Chain Leaders
• Quality Leaders
• IT Support
Gary Saner, Sr. Manager, Information Solutions Life Sciences, Reed Tech
Gary Saner is a subject matter expert on medical device unique device identification and other structured content reporting to regulatory agencies and commercial organizations. He has over 30 years of experience in software development, process management and data administration with the last 15 years focused on the life sciences industry. He serves as Co-Chair of the industry’s Structured Product Labeling Technical Team and on the Advisory Board of the Medical Devices Group.
Patti Shragher, Senior Account Executive, Life Sciences, Reed Tech
Patti Shragher enjoys solving problems with technology and takes pride in strategic challenges. She consults with customers and prospects all over the globe on Reed Tech solutions for regulatory compliance, product data management, UDI submissions and data syndication.
Patti is a multi-lingual (English, Spanish and Portuguese) business development professional with both US and international experience. She earned her MS from Purdue University and an MBA from Budapesti Corvinus Egyetem (Budapest, Hungary).
Reed Tech is the provider of best-in-class information-based solutions and services to meet the needs of the life sciences industry, government agencies, and the intellectual property market. Our customers are located throughout the world and include a wide range of medical device manufacturers and pharmaceutical companies, the U.S. government, numerous Patent Authorities, and IP-driven companies and law firms. The corporate mission is to advance humanity by delivering better outcomes to the innovation community. Reed Tech is a LexisNexis company.
For more information: MedDevice@ReedTech.com, +1-215-557-3010