This week we got together with a very motivated group of medical device manufacturers, as well as friends from Zebra Technologies and Flexcon, to discuss how to come up with a plan to meet the FDA’s new UDI Rule. Since the ruling was only published in late September, there were a lot of great questions […]
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Ensure UDI Success
With the FDA having published their UDI Mandate on September 24th, labeling and marking of medical devices is going to be a hot topic in the industry. Along with our good friends at Zebra Technology we are hosting an educational seminar “Ensuring UDI Success – Labeling & Marking for Medical Devices”. If you are in […]
UDI Rule Published At Last
The FDA has finally published the final rule on Unique Device Identification. On September 2o, 2013 , Jay Crowley, Senior Advisor for Patient Safety, Center for Devices and Radiological Health, Food & Drug Administration (FDA) and the regulator responsible for FDA’s UDI effort, made the announcement at the UDI conference in Baltimore, MD. The ruling will […]
What You Need to Know About UDI
As a medical device manufacturer, you need to be aware of the FDA’s UDI rule, and know what you need to do to comply. Simply put, the FDA rule, proposed in July 2012, requires medical device manufacturers to label their products with a unique device identifier, or UDI. The purpose of the UDI is to […]
UDI Acronyms Explained
If you are involved with UDI labeling, then you know how confusing it can be to understand all of the acronyms involved in FDA’s proposed Unique Device Identification rule for the medical device industry. Watch this video by Tom Beatty and Bruce Fieggen of QPharma Inc. so you can make sense of the confusing terms […]
FDA UDI Resources
There is a lot of information on the FDA Unique Device Identification program scattered around the web and I thought it would be a good idea to post links to some of the best resources – I started this more my own benefit, but it might help others with an interest in this topic. If you are […]
BIOMEDevice Boston – FDA UDI Labeling
If you are in the New England area and involved in the medical device industry, chances are you’ll be visiting the BIOMEDevice Show in Boston. You are probably also wondering about the proposed Unique Device Identification (UDI) rules from the FDA will affect your labeling operations. We’ll be there at Booth 247 and will be showing how companies […]
Medical Device Manufacturers: UDI Isn’t Going Away
If you work in the medical device manufacturing or healthcare industry, you’ll want to understand the issues behind the UDI task force. Take a few minutes and watch this video from GS1 called, “Standardization….Stat! Improving the Healthcare Supply Chain with Data Standards.” Now you can see why a unique, global identifier is needed to ensure product/equipment […]
Preparing For UDI
The FDA has recently updated its draft version of the UDI rule to include its proposal for the UDI system and tracking database. The Global Unique Device Identification Database (GUDID) would keep track of all medical devices’ unique identifiers. In a previous draft (July 2010), the FDA defined a phased in approach to compliance depending […]
GS1 Addresses UDI Labeling Concerns
A final ruling on UDI implementation is expected this year, causing medical device manufacturers to hasten implementation of a UDI system. Some manufacturers, however, think that implementing a system for labeling and tracking medical devices will take longer than expected by the FDA. If you are a medical device manufacturer trying to figure out how […]