After two delays, the Unique Device Identification (UDI) GUDID submission deadline is now a few months away with a deadline of December 8, 2022.
FDA published a Final Guidance concerning Class I medical devices on July 22.
Specific to eyewear, the Vision Council leadership has identified 4 key takeaways from the Final Guidance that members should be aware of.
• Plano sunglasses and OTC readers must fully comply with UDI labeling and GUDID reporting.
• Because spectacle frames do not have lenses that require impact-resistant testing, they are not 'restricted devices'. As such they are exempt from GUDID reporting per the guidance document as consumer health products.
• The Vision Council is awaiting final decision on whether spectacle frames are completely exempt from UDI labeling, as that exception request is still pending.
• The new UDI compliance date is December 8, 2022, for GUDID reporting.
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 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.
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.
Andrew Pfeifer, Account Executive & Team Lead, Medical Devices
Andrew Pfeifer 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.