Serialization/Unique Device Identification

8 potential UDI code readability issues and the critical role of vision

Sep 30, 2016

September 2016 brings several key deadlines for Unique Device Identification (UDI), a system of medical device identification rules issued by FDA in 2013. UDI requirements state that the device labeler, in most cases the manufacturer, must include...

Best practices in serialization

Jan 20, 2016

Seven essentials can help companies execute serialization strategies across multiple product lines, multiple packaging lines, and regional markets around the world.The world of pharmaceutical packaging is replete with confusing and disruptive...

Pharma industry seeks track-and-trace law

Jan 20, 2016

By David Vaczek With the RxTEC Act, pharmaceutical supply chain members are proposing a phased-in approach to track-and-trace with a federal law imposing uniform requirements on all states. The act was developed by the Pharmaceutical Distribution...

Prepare for serialization, track & trace while at Pharmapack Europe

Jan 20, 2016

“Introduction of counterfeit products in the normal international supply chain poses particular issues for pharmaceutical companies, both from direct risk to their customers and to their own reputation within what is a highly competitive industry...

Authentication throughout the supply chain

Jan 20, 2016

California’s State Board of Pharmacy (CA BoP) met this week to begin preparing for implementation of the state’s electronic pedigree requirements. CA BoP hosted Connie T. Jung, FDA’s acting associate director for policy and communications in the...

Senate, Congress pass national drug traceability legislation

Jan 20, 2016

The US Senate by voice vote today passed the Drug Quality and Security Act/H.R. 3204, pharmaceutical traceability legislation that establishes a national requirement for tracing of pharmaceuticals through the supply chain.In preempting...

Healthcare supply chain executives ask for release of FDA's proposed UDI rule

Jan 20, 2016

A group of health care organizations have written a letter to Jeff Zients, Acting Director of the Office of Management and Budget (OMB), asking for the release of FDA's proposed rule on Unique Device Identifiers (UDIs). According to FDA, Section...

Medical device companies prepare to implement Unique Device Identification

Jan 20, 2016

With a final rule from FDA for UDI expected this year, device makers have accelerated development of a UDI system. As a first step, “labelers” need to adopt a system for issuing UDIs from an issuing agency accredited by FDA. Support continues to...

Be penny wise

Dec 31, 2015

Can a medical device that costs pennies actually end up costing a hospital thousands of dollars? Perhaps. Consider this scenario: “Using latex gloves as an example, with 50 distributors each assigning their own item number to each box of latex...

UDI: Are you ready for September 24? GS1 Healthcare US's new head working to support medical device manufacturers on UDI and other changes

Dec 30, 2015

Michael Innes, former Kaiser Permanente Program Director, has joined GS1 US to lead GS1 Healthcare US.PMP News Editor Daphne Allen asks for details on how he and the organization will help medical device manufacturers prepare for UDI and other...

Serialization/Unique Device Identification

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