Reed Tech Webinar | FDA Class I UDI Requirements & Exemptions

Is your organization manufacturing US FDA Class I medical devices? After two delays, the Unique Device Identification (UDI) compliance date is now a few months away on September 24, 2022.

To comply, device product information needs to be reported 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.

Join our panel, including Terrie Reed, former UDI lead at the FDA, for a walk-through of the US FDA Class I medical device UDI requirements, exceptions, and use cases. Our panel will share key lessons learned from previous device class UDI implementations and industry adoption that will help shape your US and global UDI approach.

UDI definition and goals
FDA UDI Requirements & Class I Exceptions
Label Data vs. GUDID submission data
The importance of label standardization
FDA GUDID Compliance: Submission/Maintenance
How manufacturers can improve industry adoption and use of UDI data
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 are less than 150 days away. UDI preparation can be complex and time-consuming without subject-matter expertise.

Terrie Reed, Director of Partner Relationships, Symmetric Health Solutions
Terrie has spent the past 15 years advocating for a safer, better-functioning medical device ecosystem. As FDA Associate Director of Informatics and later as Senior Advisor for UDI Adoption, she coordinated across multiple stakeholders (government agencies, standards development organizations, industry, and healthcare systems) advocating for the use of UDI and the data in Global Unique Device Identification Database (GUDID) as a public regulatory source of device identification information.

In her role as Director, Partner Relationships at Symmetric Health Solution, Ms. Reed has seen first-hand the power of UDI to improve the efficiency of the healthcare supply chain and link to clinical data in hundreds of hospitals that are choosing to replace custom product identifiers with a scannable globally unique identifier tied to standard information stored in FDA’s AccessGUDID.

Rich Kucera, CEO and President, Symmetric Health Solutions
Mr. Kucera is CEO and a co-founder of Symmetric Health Solutions, a healthcare supply-chain data aggregation, cleansing, and enablement company with products used by over 600 hospitals. He specializes in healthcare provider back-office data management, analytics, procurement, and inventory management.

Before Symmetric, Mr. Kucera led business-transformation and analytics teams at hospitals as a Manager in Accenture's Health and Public Services practice. During this time, he analyzed procurement data for thousands of hospitals, both across US and overseas. Unable to meet the data needs of both downstream data consumers and of executives with the current industry tools, Mr. Kucera co-founded Symmetric with a focus on regulatory standards.

Mr. Kucera leverages his understanding of healthcare supply data chain to lead Symmetric in solving the ongoing challenges facing the industry today.

Gary Saner, Senior Manager Information Solutions

Gary 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.

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.

Symmetric improves healthcare supply chain visibility by providing organizations with cleansed, comprehensive medical product data. Over 600 hospitals across the US and overseas use Symmetric’s suite of software products to improve supply chain operations, from our web application to item data feeds and our point-of-use scanning application. Our products provide customers with refreshed data for the attributes they care about most, including GTINs, item descriptions and classifications. Follow them on LinkedIn.

WEBINAR

The Date is Approaching for U.S. Class I Devices to Comply with UDI:

Requirements and Exceptions

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Is your organization manufacturing US FDA Class I medical devices? After two delays, the Unique Device Identification (UDI) compliance date is now a few months away on September 24, 2022.

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