Explore our library of blogs, short videos, virtual event recordings and training topics
What are the potential consequences for medical device manufacturers not following through with product data submissions and labeling requirements? In a recent inspection, violations were identified regarding a manufacturer’s Unique Device Identification (UDI)...
Courtesy notification of news from FDA: The U.S. Food and Drug Administration (FDA) recently initiated two initiatives to improve the completeness and quality of the Global Unique Device Identification Database (GUDID). As a medical device manufacturer or other...
With the US Class I UDI enforcement quickly approaching, you may be wondering “what about older inventory”? In 2013, the FDA granted a UDI exception for 3 years after the corresponding Compliance Date for finished medical devices manufactured and labeled without...
Did you know? The FDA Class I deadline enforcement is occurring on December 8, 2022. Many in the medical device industry make plans to use the free FDA Web Interface based on the assumption that they don’t have enough products to warrant the use of Structured Product...
Did you know there are multiple health authorities around the globe with current or future requirements for medical device product data specifically for Unique Device Identification (UDI) standards? The list continues to grow (US FDA, EU EUDAMED, South Korea MFDS,...
Medical device manufacturers working to comply with the FDA’s Unique Device Identification mandate have more than one set of regulations to keep in mind. Fortunately, some of the regulations have been in place for some time and will be at least somewhat familiar to...
If you are involved in your organization’s compliance program for Unique Device Identification (UDI), you have probably heard a lot of “G terms” being thrown around, such as “GS1,” “GTIN” and “GDSN.” But what do these terms mean and where do they fit in with UDI...
As you work on implementing UDI, you may be wondering how to assign the Device Identifier (DI) portion of the UDI to your products and how to make sense of the different levels of DIs in a single GUDID record. These are questions we receive from industry members all...
Unique Device Identification (UDI) product data submissions require not just that your system for sending data to the FDA’s Global Unique Device Identification Database (GUDID) be in place and functioning smoothly. It requires that the data you send through that...
Some medical device manufacturers seeking to comply with the FDA’s final rule on Unique Device Identification may want to turn to outside firms for help throughout the process. Others may already have the expertise in-house to handle their UDI compliance and FDA GUDID...