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Leveraging GS1 standards and services in marketplaces

The establishment of Global Standards, a nonprofit organization that standardizes business information globally,  leverages GS1 standards and services in the marketplace providing a faster listing process, improved counterfeit detection, and simplified regulatory compliance. GS1 is a common language to identify, capture, and share information globally. GS1 Standards provide unique identification of items and products that […]


How the FDA handles drug shortages

  We have heard a lot through the news lately of drug shortages, mostly over-the-counter cold and flu medications, but what is the process when prescription drugs are in short supply?  The FDA works closely with the pharmaceutical industry and stakeholders to “prevent drug shortages and lessen the impact on patients anytime there is a […]


Doctor indicted for adulterating medical devices

  A doctor in Raleigh, North Carolina was indicted for the extreme misuse of a medical device in addition to Medicare fraud and making and using materially false Healthcare Documents.  Many of the patients were misled by thinking the medical device, was sterile and was used for the first time during their surgery. A balloon […]


Unique Device Identification System (UDI)

The FDA established the Unique Identification System (UDI) to identify medical devices sold in the US from the point of manufacturing and distribution all the way to patient use. The UDI final rule requires device labelers to: Include a UDI on device labels and packages, except where the rule provides for an exception or alternative. […]


How do I manage all the projects that I have and still get compliant on UDI?

UDI requirements for class 3 and class 2 devices are now behind you, but the compliance standards continue to emerge and you must maintain the ones you have already completed. Maybe your organization is impacted by all three (3) UDI class distinctions, or MDR (European UDI) standards, or you  have additional requirements to maintain these […]


FDA UDI Class I

Several dates for UDI compliance have been postponed: •         Class I and unclassified devices – 24th of September, 2020 •         Direct Marking of Class I and unclassified devices – 24th of September 2022 Low-risk devices are required to follow the UDI ruling two years later than it was originally planned (24th of September 2018). Class […]


FDA Extends Mandates for Certain Class II Devices

The US Food and Drug Administration (FDA) is extending the deadline to comply with unique device identifier (UDI) requirements for certain Class II devices. The first mandate posted was that all Class II devices must be in compliance by September of 2016. Now, FDA says it is extending the compliance date for certain Class II […]


Benefits of a UDI System

When we talk about UDI in our industry, we always refer to the classes, Class 3, Class 2 and Class 1 UDI and we always reference the due dates. What gets lost in this discussion is the actual benefits that accompany UDI. When UDI is fully implemented there are benefits to multiple organizations: the organization […]


Preparing to Meet UDI Compliance Dates

The healthcare industry has been rapidly preparing for FDA compliance requirements, on all medical devices (Class I-Class III.)— With the FDA’s latest deadline being completed for Class II devices this September, are you prepared for the Class I deadline? With each UDI deadline provide a new challenge for the medical device community. While many companies […]


Upcoming UDI Class III and Class II Compliance Dates

We are nearing almost 3 years of the original publication of the UDI final ruling.  What this means to medical device manufacturers is that we are just over a month away (September 24, 2016) for certain deadlines around Class III and Class II devices and packaging. Class III regulations due Sept. 24th: UDI required devices […]