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Reed Tech Life Sciences representative Patti Shragher attended The Vision Expo West 2022 conference, on September 14th – 17th. This year's event took place at the Venetian Convention Center & Expo in Las Vegas, Nevada. We asked a few questions about her...
Update on FDA Class I UDI as of July 22, 2022 Final guidance has been issued by the US Food and Drug Administration (FDA) for labelers of Class I medical devices. In an effort to help the industry remain focused on high-quality Unique Device Identification (UDI)...
Pop quiz: For the purposes of FDA Unique Device Identification (UDI), is an anterior cruciate ligament (ACL) procedure kit considered one medical device, i.e., a “convenience kit?” That question is one of many addressed by the FDA’s final guidance on Unique Device...
Is your team evaluating UDI regulatory submissions for EU and other regions? All the complexity around UDI regulatory (and commercial) requirements across the globe create serious challenges for product data management. When considering what’s at stake, a...
The FDA Unique Device Identification (UDI) regulation requires manufacturers to identify their medical devices with a UDI placed on their product and package labels. Of equal importance, the FDA UDI regulation also requires manufactures to report medical device...
What is the Global Data Synchronization Network? The GDSN is the largest online product data network. It’s a secure network that allows any agents, such as manufacturers, retailers, distributors, and wholesalers to share validated product information. Because of its...