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As medical device manufacturers scramble to meet Unique Device Identification (UDI) deadlines, a risk-based approach to UDI compliance will help ensure continuity within the quality system, consistency in UDI practice and application, accuracy of the associated data...
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...
When medical device manufacturers prepare to submit their device data to the FDA in compliance with Unique Device Identification requirements, one of the prerequisite steps for all manufacturers is to establish a Global Unique Device Identification Database account....
Leaders of the regulatory and labeling departments of a medical device manufacturer likely know that complying with the FDA’s final rule on Unique Device Identification (UDI) takes time and planning. But convincing the executives in the C-suite to allot the necessary...
After working with a number of medical device companies to successfully submit device records to the FDA, one important piece of advice from the experts at Reed Tech is to start by gathering the right team members from the beginning. Initially, many in the medical...
As Implantable, Life-Sustaining and Life Supporting (I/LS/LS) and Class II medical device labelers have complied with the FDA’s final rule on Unique Device Identification (UDI), one of the first major decisions they needed to make: choose a device identifier (DI)...
As part of the FDA’s Unique Device Identification (UDI) mandate, medical device labelers are required to submit a data record for the devices they market in the United States to the FDA’s Global Unique Device Identifier Database (GUDID). But who does the FDA consider...
In preparing for compliance with the U.S. Food and Drug Administration's final rule requiring Unique Device Identifiers (UDIs) for medical devices distributed in the U.S., there are a number of steps that device manufacturers should be aware of before submitting data...