WEBINAR

FDA UDI Class I Submission is Due in One Month

Ask About Requirements and Exceptions

Thursday, November 3, 2022   11:00am EDT

Learn industry specifics about UDI submissions for the US FDA Class I Deadline 

After two delays, the Unique Device Identification (UDI) GUDID submission deadline is now one month away with a deadline of December 8, 2022. 

FDA published a Final Guidance concerning Class I medical devices on July 22.

In this webinar, we will cover the following subjects:

• UDI definition and goals
• FDA UDI Requirements
• Label Data vs. GUDID submission data
• FDA GUDID Compliance: Submission/Maintenance
• 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. Get started now! UDI preparation can be complex and time-consuming without subject-matter expertise.

Key Takeaways

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

Speakers

Gary 350x350

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.

LINDA

Linda Morehouse, Account Executive, Medical Devices

Linda Morehouse is a RAPS certified UDI global compliance expert with many years of experience helping medical device organizations implement a cost effective UDI solution.

 

 

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