Medical Labels
Apr 10, 2017
Here’s how to cope with new EU Medical Device Regulations requiring unique device identification. Peter Rose Back in 2014, the Department of Health started to...
Oct 04, 2016
Marie Thibault In an "early alert," the Office of Inspector General for Health and Human Services (HHS OIG) has asked CMS to work to add device identifier...
Aug 30, 2016
Marie Thibault Device makers have three more years to meet a particular requirement of the Unique Device Identifier (UDI) rule. FDA has issued final guidance...
Aug 17, 2016
Tips and tricks for medical device manufacturers to ensure they meet the upcoming UDI deadline. Steve Cottrell and Madris Tomes The American Hospital...
Jan 15, 2016
Marie Thibault Proponents of linking unique device identifiers (UDIs) to insurance claims forms have found an unlikely silver lining. These supporters ...
Jun 25, 2015
Marie Thibault As part of its unique device identifier rule, FDA has published draft guidance, "Unique Device Identification: Direct Marking of Devices,...
Jun 02, 2015
Here are some tips for medical device manufacturers to effectively implement the UDI rule and facilitate improved patient care and supply chain management....
May 18, 2015
Marie Thibault The long shelf life and uncommon business model of orthopedic implants is presenting a hitch in implementing FDA's Unique Device Identification...
Mar 26, 2015
Manufacturers must realize that the new FDA medical device database makes data its own product. Rajesh Misra and William Poetker FDA rules require medical...
Mar 02, 2015
Marie Thibault In recent years, there have been large-scale incidents of patients sharing insulin pens, and FDA wants to put a stop to it. In a safety...