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Learn more about the US FDA Class I Deadline
After two delays, the Unique Device Identification (UDI) submission date is now a few months away with a deadline of December 8, 2022 (the prior date was September 24, 2022).
FDA published a Final Guidance concerning Class I medical devices on July 22.
If your product is sold directly to professional healthcare facilities, only used by healthcare professionals, or requires a 510(k), you must report product data to GUDID.
To comply, device product information needs to be submitted to the FDA GUDID (database); UDI needs to be placed on product labels and in some cases directly on the product. The FDA has provided general UDI exceptions, and some additional exceptions just for Class I devices. Identifying what is required for your portfolio can be difficult, but it is important to get it right as the supply chain, healthcare providers, and patients depend on accurate product data.
If you are unsure if this applies to your products, join us for a walk-through of the US FDA Class I medical device UDI requirements, exceptions, and use cases. We will share key lessons learned from previous device class UDI implementations.
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 Manufacturers can Improve Industry Adoption and use of UDI Data
• Planning your UDI data strategy for the US (and Global) Market
• 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 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 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 sustainable and cost effective UDI solution.
