Medical Device Development the Focus of FDA Public Workshop in June
Thanks to a recent article in The Massachusetts Medical Devices Journal, which is a very fine online site that covers the medical devices industry in Massachusetts and New England, I was alerted to an upcoming FDA public workshop to be held on June 24th in Gaithersburg, Maryland. The theme of the gathering is: Identifying Unmet Public Health Needs...
UDI Perspectives and Timetables Explained by FDA Senior Advisor in Recent Article
This is an important update to the Food and Drug Administration’s (FDA) timelines for UDI (Unique Device Identification) implementation deadlines. It comes by way of a recently published article entitled, “The FDA’s Take on Unique Device Identification,” authored by Jay Crowley who is senior advisor for patient safety for the Food and Drug Administration’s Center for Devices...
A ground-breaking white paper: Compliance with UDI Labeling Mandates: A Proven Methodology
We have a brand new and very compelling White Paper just out. Compliance with UDI Labeling Mandates: A Proven Methodology, was produced because, as the introduction states: There has never been a better or more urgent time for manufacturers of healthcare products to make a close examination of their product labeling systems. If you read...
Annual Cost of Foodborne Illness in US: $152 Billion
Thanks to a recent initiative of The Pew Charitable Trusts, for the first time in American history someone has finally put a price tag on what it costs people in the United States each year who get sick from bad food. After crunching all the numbers, the grand total comes to $152 billion (yes, that’s...
Loftware's UDI Webinar #3 on Feb. 9th: "Step 2: Integrate – Managing Your Labeling Data Systems Effectively"
For the third in our series of webinars, which occurs February 9th at noon eastern time, the attention will be on these core questions: “How do I get started? Where do I start? How do I tackle today’s problems, yet stay ready for future compliance changes?” We’re tackling these questions because when you’re involved with...
In Letter to Congress, Premier Urges Support for Medical Device UDI
Thanks to Health Data Management we have this recent news about a letter penned by Premier, Inc., to U.S. House and Senate members asking them to retain the medical device Unique Device Identification (UDI) provision in any healthcare reform bill. The news item was written by Joseph Goedert. In it, he quotes the most relevant paragraph from Premier’s...
Report on FDA's Prototype UDI Database Apt to Spur Questions at our Jan. 12th Webinar
This is very interesting. At the FDA News web site you’ll see a brief item entitled, “Devicemakers Question Data Requests for FDA’s Prototype UDI Database.” The first sentence seems to imply there may be much work ahead to finalize a UDI approach that satisfies everyone. The sentence is: Devicemakers testing a unique device identifier (UDI)...
Webinar: How Can You Quickly Adopt Data Standards for Unique Device Identification?
Loftware is pleased to announce, as an extension of our blog, a series of educational webinars to focus on the process of meeting unique device identification requirements and the adoption of GS1 data standards. Our kick-off session will be held on December 1, 2009 and registration can be found here. This first session will focus...
VHA Asks FDA for Speedy UDI Decision; Inclusion of Only GS1 Standards as Single Mandatory Solution
This news comes from Healthcare Purchasing News: VHA Inc. and 13 of its largest health system members have sent a letter to the U.S. Food & Drug Administration requesting prompt issuance of Unique Device Identification (UDI) regulations, and that those regulations include GS1 supply chain standards. At this link, you can see the full release direct...
FDA Launches New 'Safe Use Initiative' to Reduce Medication Errors
I go to the U.S. Food and Drug Administration (FDA) website almost every day to glimpse their recent news releases. That’s because sometimes their announcements don’t seem to get much pick up in the usual places. Yesterday they issued this news release. The headline is: FDA Unveils Safe Use Initiative that Targets Preventable Harm from Medication...
Online Videos and Presentations from 15th Global GS1 Healthcare Conference Now Available
GS1 has alerted us to the availability of online videos and presentations captured in Hong Kong in early October during the GS1 Healthcare Conference.
First View of FDA UDI Regulations . . . Just Hours Away?
This is a reminder of the UDI 2009 Conference that gets underway twelve hours from now, in Orlando. Take a look at this event site and tell me it doesn’t have ‘decision-time’ written all over it.
GHS and Regulatory Labeling Challenges in the New Era 
