FDA Gives UDI Extension for Low-Risk Medical Devices

OMEDtechNews & Events

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Unique Device Identifier Convenience Kit Draft Guidance

OMEDtechDraft 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The FDA has released a draft guidance: Unique Device Identifier Convenience Kit.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

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Unique Device Identification: Direct Marking of Devices – Draft Guidance Overview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The Unique Device Identification: Direct Marking of Devices draft guidance has been released by the FDA.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

UDI Extension

OMEDtechNews & Events

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

UDI Update

OMEDtechNews & Events

The first deadline for the UDI rule is approaching.  The FDA released their final rule for UDI on September 20, 2013.  Most medical devices will require a UDI or Universal Device Identifier within the next seven years.  The UDI will have many benefits such as improved product information and faster product identification for problems or recalls. The following timeline shows … Read More