With initial deadlines for FDA’s Unique Device Identification rule to begin phasing in later this year, medical device manufacturers are busy studying the regulation and looking for implementation support. On February 11, attendees at Medical Design & Manufacturing West 2014 got the chance to see potential solutions on the “Get UDI Ready” show floor tour.
As the medical device industry begins to prepare for Unique Device Identification, FLEXcon has launched FLEXcon MedFLEX, a line of label substrates designed to meet FDA’s performance requirements. The FLEXcon MedFLEX line can support unique coding as well as comply with rub tests, the company reports. Specifically, the line is UL-certified in accordance with UL/IEC 60601-1 3rd edition marking durability rub tests, the company reports, and three of the products are UL-recognized with inks and ribbons.
FDA's Jay Crowley will participate in a new general session keynote panel at GS1 Connect 2013 called “Held to Higher Standards: Doing Business in a Digital World.” Panelists will discuss the digital transformation taking place in business and global commerce. The panel, moderated by GS1 US President and CEO, Bob Carpenter, will include:
AIM North America (AIM NA), the Association for Automatic Identification and Mobility in North America, reports the following new committee leaders for 2013:
These industry experts have been elected chair of their respective committees for one year.
The agency’s proposal would require most medical devices distributed in the United States to bear UDI, and in certain instances UDI would need to be marked directly on the device. These include devices that would remain in use for extended periods of time and would be likely to become separated from their labeling, the draft reads.
No national requirement for pharmaceutical track and trace has materialized to supersede California’s 2015 law, and Unique Device Identification has just been proposed in draft form.
With U.S. mandates slowly emerging, pharmaceutical and medical device companies should consider business needs as they prepare for unique product coding, GS1 representatives urge. The identification standards organization promotes its systems for standardizing product identification throughout the supply chain.