GUDID Enhancements The GUDID system will soon undergo enhancements. These improvements will allow the system to continue meeting user and program needs. The GUDID Release 2.3 will include the public release of the Premarket Submission Number and the Supplement Number which will become part of each GUDID DI record. Before the GUDID enhancements are implemented, the FDA suggests that users … Read More
FDA Gives UDI Extension for Low-Risk Medical Devices
FDA Issues Letter to UDI Device Labelers The FDA has provided a notice to device labelers with an update on the Unique Device Identification (UDI) compliance dates. Originally, the UDI was to be marked on labels at different time frames with regard to the classification level of the device. The FDA has extended UDI compliance dates for certain types of … Read More
Unique Device Identifier Convenience Kit Draft Guidance
The FDA has released a draft guidance: Unique Device Identifier Convenience Kit. This document further explains the phrase “convenience kit” and how it applies to the UDI rule. The FDA released their final rule for UDI on September 24, 2013, requiring most medical devices to label a UDI. The UDI will have many benefits such as improved product information and … Read More
GUDID Data Submission Compliance Update
The unique device identification (UDI) rule is being implemented by device classification, with varying compliance dates to the Global Unique Device Identification Database (GUDID). The GUDID system was temporarily taken offline on August 7, 2015 for security reasons. Since the system was unavailable the FDA has decided to extend the September 24, 2015 compliance date for the implantable, life-supporting and … Read More
Unique Device Identification: Direct Marking of Devices – Draft Guidance Overview
The Unique Device Identification: Direct Marking of Devices draft guidance has been released by the FDA. A UDI is required to be directly marked onto a device if it is “intended to be used more than once and reprocessed before each use.” (FDA) Directly marking a UDI on reprocessed devices helps to maintain accurate information and keeps the UDI in contact with … Read More
AccessGUDID Open for Public Use
AccessGUDID is now open for public use. The FDA has released data for devices with unique device identifiers (UDI) to the public through a website called AccessGUDID. The FDA’s final guidance in 2013 explains the UDI purpose and requirements. A UDI must be included on most device labels and packages, and device identification information must be submitted to the FDA’s Global Unique Device … Read More
UDI Update
The FDA’s Center for Devices and Radiological Health (CDRH) has issued an update on the upcoming Unique Device Identifier (UDI) requirements. Upcoming compliance dates for UDI requirements are: September 24, 2015 for non-class III implantable, life-supporting, and life-sustaining (I/LS/LS) devices September 24, 2016 for class II devices Upcoming dates for Global Unique Device Identification Database (GUDID) Data Submission: January 2015, they will … Read More
UDI Extension
The FDA released their final rule for UDI on September 20, 2013. Most medical devices will require a UDI or Universal Device Identifier. The UDI will have many benefits such as improved product information and faster product identification for problems or recalls. The UDI is a unique code made up of two parts. The UDI Rule gives criteria for labeling, … Read More
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