GUDID Update – Premarket Submission Supplement Number

OMEDtechNews & Events

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

GUDID Data Submission Compliance Update

OMEDtechNews & Events

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Unique Device Identification: Direct Marking of Devices – Draft Guidance Overview

OMEDtechDraft Guidance

The Unique Device Identification: Direct Marking of Devices draft guidance has been released by the FDA.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

OMEDtechNews & Events

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

OMEDtechNews & Events

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


OMEDtechNews & Events

The UDI final rule states that information about a device with a UDI must be submitted to the Global Unique Device Identification Database (GUDID). The GUDID is a public database organized by the FDA and will be a reference tool for devices with a UDI. This database will use only the DI (device identifier) portion of the UDI to identify … Read More