Our Loftware partners conducted a recorded webinar discussion with pharma experts about how regulatory labeling challenges impact the global pharmaceutical industry. During this webinar, the conversation covered: Standardizing global labeling operations Integrating labeling with existing business applications Increasing supply chain efficiency and agility The opportunity to hear from industry experts with firsthand experience working within […]
The Universal Device Identification (UDI) system was developed by the U.S, Food and Drug Administration (FDA) as global UDI compliance to protect patients and clinicians by improving traceability of medical devices through a common and shared system. It has and continues to fulfill its role in safety and traceability tenfold and medical device software has […]
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 […]
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 […]
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 […]
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. […]
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 […]
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 […]
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 […]