If you work in the medical device industry, you've likely heard of Unique Device Identifier (UDI). In recent years, UDI has become increasingly important for medical device manufacturers, as it allows for more efficient tracking of devices and improved patient safety. But what exactly is UDI, and how does it work? In this comprehensive guide, we'll cover everything you need to know about UDI, including its definition, history, and regulatory requirements. What is UDI?UDI is a unique code assigned to medical devices by the manufacturer. The code includes information such as the device's model, manufacturer, and production information. The purpose of UDI is to allow for more efficient tracking of devices throughout their lifecycle, from production to distribution to patient use. UDI RequirementsThe FDA's UDI rule requires medical device manufacturers to label their devices with a unique code consisting of a device identifier (DI) and a production identifier (PI). The DI is a unique code assigned by the manufacturer that identifies the device's model, while the PI includes information such as the device's lot or serial number, manufacturing date, and expiration date. The UDI must be both human-readable and machine-readable, such as in a barcode or RFID tag. Benefits of UDIUDI offers numerous benefits for medical device manufacturers, healthcare providers, and patients. For manufacturers, UDI allows for more efficient tracking of devices throughout their lifecycle, from production to distribution to patient use. This can help manufacturers identify and address quality issues more quickly and reduce the risk of product recalls. For healthcare providers, UDI can improve patient safety by ensuring that the correct device is used for each patient and allowing for more accurate tracking of adverse events. For patients, UDI can provide greater transparency and confidence in the safety and effectiveness of medical devices. UDI ImplementationThe FDA's UDI rule has been phased in over several years, with different compliance dates for different types of devices. As of September 24, 2022, all Class II medical devices must bear a UDI on their labeling, and all Class I and unclassified devices must bear a UDI on their labeling or packaging. In addition, the FDA has established a Global Unique Device Identification Database (GUDID), which serves as a repository for UDI information and allows for easy access to device information by healthcare providers and patients. FAQsWhat is the purpose of UDI?UDI is a unique code assigned to medical devices by the manufacturer. The purpose of UDI is to allow for more efficient tracking of devices throughout their lifecycle, from production to distribution to patient use. What is the history of UDI?The UDI system was first proposed by the US Food and Drug Administration (FDA) in 2007. In 2013, the FDA finalized its UDI rule, which required medical device manufacturers to label their devices with a unique code.
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