• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
    • Cardiovascular
    • Orthopedics
  • Wall Street Beat
    • Funding Roundup
    • Mergers & Acquisitions
  • Podcasts
    • MPR: Breakthrough Products Series
  • Resources
    • About MassDevice
    • Newsletter Signup
    • Job Board
    • Leadership in Medtech
    • Manufacturer Search
    • MedTech 100 Index
    • Videos
    • Whitepapers
  • DeviceTalks Tuesdays
    • DeviceTalks
  • Coronavirus: Live updates

Unique Device Identifier (UDI)

FDA names GS1 to manage medtech identifiers | MassDevice.com On Call

December 20, 2013 By Arezu Sarvestani Leave a Comment

MassDevice.com On Call

MASSDEVICE ON CALL — FDA regulators appointed Belgium’s GS1 to manage its medical device Unique Device Identifier program, issuing IUDs and helping manufacturers keep up with requirements of the program.

GS1 is a not-for-profit global organization that develops and maintains what is says are the "most widely used supply chain standards in the world," affecting a variety of industries and incorporating voices from business, government, communities and other partners.

Filed Under: Food & Drug Administration (FDA), News Well, Regulatory/Compliance Tagged With: On Call, Unique Device Identifier (UDI)

Update on US FDA Unique Device Identification Submission System

December 3, 2013 By MassDevice Leave a Comment

Update on US FDA Unique Device Identification Submission System

By Stewart Eisenhart, Emergo Group

The US Food and Drug Administration has published draft technical specifications related to its Unique Device Identification (UDI) rule finalized earlier this year.

Filed Under: Food & Drug Administration (FDA), News Well Tagged With: Emergo Group, Unique Device Identifier (UDI)

New FDA UDI requirements to be phased in over 7 years

September 26, 2013 By MassDevice Leave a Comment

Global Medicine

By Stewart Eisenhart, Emergo Group

A final rule from US regulators on Unique Device Identifier (UDI) requirements will begin taking effect by late 2013 in an effort to reduce errors caused by misidentification of medical devices.

Filed Under: Food & Drug Administration (FDA), News Well, Regulatory/Compliance Tagged With: Unique Device Identifier (UDI)

Identifying medical devices will strengthen safety

September 20, 2013 By MassDevice Leave a Comment

Identifying medical devices will strengthen safety

By: Jeffrey Shuren, M.D., J.D. 

Medical devices are an important part of everyday life for many people. Some are used to diagnose, others to treat patients. Some are implanted in the body. Some are used by doctors in hospitals, while others are used by patients in their home or at work. 

Filed Under: Food & Drug Administration (FDA), News Well, Regulatory/Compliance Tagged With: Patient Safety, Unique Device Identifier (UDI)

FDA’s new Unique Device Identifier rule addresses some, not all, industry concerns

September 20, 2013 By Arezu Sarvestani Leave a Comment

Updated September 20, 2013, at 3:30 p.m. with comments from the Medical Device Manufacturers Assn.

FDA's new Unique Device Identifier rule addreses some, not all, industry concerns

The FDA’s updated labeling standard, including product and manufacturer name, expiration date, reference and lot no., bar code and details.

Filed Under: Food & Drug Administration (FDA), News Well, Regulatory/Compliance Tagged With: AdvaMed, Patient Safety, Unique Device Identifier (UDI)

Unique Device Identification (UDI): From compliance to competitive advantage

September 12, 2013 By MassDevice Leave a Comment

FDA UDI example

The FDA’s UDI label example: Product name, expiration date, reference and lot nos., manufacturer information, barcode, details and illustration.

By Rajeev Kapoor and Chris Paddison of A.T. Kearney Compliance

Filed Under: News Well, Regulatory/Compliance Tagged With: Unique Device Identifier (UDI)

New IMDRF guidance sheds more light on UDI for medical devices

April 25, 2013 By MassDevice Leave a Comment

Global Medicine

By Stewart Eisenhart, Emergo Group

The International Medical Device Regulators Forum (IMDRF), formerly known as the Global Harmonization Task Force or GHTF, has published long-awaited draft recommendations for Unique Device Identification (UDI) systems (PDF) for medical devices.

Filed Under: Blog, News Well, Regulatory/Compliance Tagged With: Emergo Group, Unique Device Identifier (UDI)

FDA’s next-gen medtech surveillance bets heavily on unique device identifiers

April 24, 2013 By Arezu Sarvestani Leave a Comment

FDA with magnifying glass

The FDA laid out plans to revamp its postmarket surveillance of medical devices, and a large part of that has to do with finalizing and implementing a long-awaited Unique Device Identifier program to better track and monitor devices.

Filed Under: Food & Drug Administration (FDA), News Well, Regulatory/Compliance Tagged With: Unique Device Identifier (UDI)

It’s time for a national patient identifier

March 19, 2013 By MassDevice Leave a Comment

By John D. Halamka, MD

Dr. John Halamka

Here’s a guest post from Meg Aranow, Principal at Aranow Consulting LLC.

Filed Under: Blog, Food & Drug Administration (FDA), Health Information Technology, News Well Tagged With: Beth Israel Deaconess Medical Center, Life as a Health Care CIO, Unique Device Identifier (UDI)

FDA’s new unique device ID timing cuts deadlines for some device labels by 5 years

November 20, 2012 By MassDevice staff Leave a Comment

FDA UDI example

The FDA’s UDI label example: Product name, expiration date, reference and lot nos., manufacturer information, barcode, details and illustration.

The FDA issued new timelines for its long-awaiting "unique device identifier" system for tracking and monitoring medical technology, cutting short some deadlines for implementation by as much as 5 years in order to comply with a new law.

Filed Under: Food & Drug Administration (FDA), News Well, Regulatory/Compliance Tagged With: Unique Device Identifier (UDI)

FDA to host Florida conference on long-awaited UDI program

September 3, 2012 By MassDevice staff Leave a Comment

FDA logo

Later this month the FDA will host a gathering of medical device and healthcare industry stakeholders for a discussion of the agency’s unique device identifier program for tracking and monitoring medical technology.

The federal watchdog agency is asking device makers, group purchasing organizations, healthcare distributors and other healthcare industry professionals to register for the 2-day conference, during which provide guidance on the program and how to comply with new rules for medical device labeling.

Filed Under: Food & Drug Administration (FDA), News Well, Regulatory/Compliance Tagged With: Unique Device Identifier (UDI)

  • « Go to Previous Page
  • Go to page 1
  • Go to page 2
  • Go to page 3
  • Go to Next Page »

Primary Sidebar

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Need Medtech news in a minute?
We Deliver!

MassDevice Enewsletters get you caught up on all the mission critical news you need in med tech. Sign up today.

Tweets by @MassDevice
MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion

MASSDEVICE

Subscribe to MassDevice
Advertise with us
About
Contact us

Add us on Facebook Follow us on Twitter Connect with us on LinkedIn Follow us on YouTube

Copyright © 2021 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Advertise | Privacy Policy | RSS