Unique Device Identification

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Article

Many of FDA’s Unique Device Identification requirements have already phased in.


Article

As medical device companies work to ensure compliance with Unique Device Identification, they’re still dealing with on-going tasks such as ensuring package integrity.


Article

To help medical device manufacturers meet Unique Device Identification (UDI) rules as well as satisfy other marking needs, RTP Company has introduced laser-markable thermoplastic compounds.


Article

September 2016 brings several key deadlines for Unique Device Identification (UDI), a system of medical device identification rules issued by FDA in 2013.


Article

Solutions are underway to address challenges in code reading, substrates, lighting, validation, and more. 


Article

This week marks the two-year anniversary of the publication of FDA’s final 


Article

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


Article

Unique Device Identification (UDI) will bring about a “huge global change” in the way medical devices are tracked and identified, Amy Fowler told 


Article

FDA clarifies its proposed mandate, but still has 35 questions for stakeholders.


Article

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.


Article

An identification standards body speaks out on the draft regulation for medical devices.


Article

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).


Article

Can a medical device that costs pennies actually end up costing a hospital thousands of dollars? Perhaps.


Many of FDA’s Unique Device Identification requirements have already phased in. The labels and packages of...


As medical device companies work to ensure compliance with Unique Device Identification, they’re still dealing with on-going tasks such as ensuring package integrity. A vision solutions provider believes it can take on both tasks. 

At...


To help medical device manufacturers meet Unique Device Identification (UDI) rules as well as satisfy other marking needs, RTP Company has introduced laser-markable thermoplastic compounds. The materials can be used for packaging as well as for...


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...


Solutions are underway to address challenges in code reading, substrates, lighting, validation, and more. 

By Rick Roszkowski, Senior Director of Marketing, Vision Products Business Unit, Cognex Corp. 

FDA’s...


This week marks the two-year anniversary of the publication of FDA’s final ...


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...


Unique Device Identification (UDI) will bring about a “huge global change” in the way medical devices are tracked and identified, Amy Fowler told MD&M...


FDA clarifies its proposed mandate, but still has 35 questions for stakeholders.

FDA has issued its proposed rule that would require most medical devices distributed in the United States to bear a unique device identifier (UDI). FDA believes...


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...


An identification standards body speaks out on the draft regulation for medical devices.

The Health Industry Business Communications Council (HIBCC; www.HIBCC.org) was originally...


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...


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...

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