The healthcare supply chain has seen its share of ups and downs this year. In the early months of the COVID-19 pandemic crisis, product shortages were exacerbated by a lack of supply-chain visibility.

The FDA is in the process of implementing the Unique Device Identification (UDI) System in a series of phases. Currently, all Class III and implantable, life-supporting and life-sustaining medical ...

In case you didn’t think number crunchers are taking over the world in the age of Big Data, artificial intelligence and “deep learning,” the feds just handed them another victory, this time in the ...

On June 2, 2017, the US Food and Drug Administration (FDA) announced that it plans to delay the dates by which certain Class I devices and unclassified devices must comply with the agency’s unique ...

SAN MATEO, Calif.--(BUSINESS WIRE)--Arkose Labs, the leader in digital risk intelligence, enabling genuine users, mitigating bots and advancing fraud detection modules, today announced the launch of ...

PITTSBURGH--(BUSINESS WIRE)--Rimsys, a world-leading Regulatory Information Management (RIM) software platform for medical technology companies, announced the release of an innovative and automated ...

The Obama Administration’s Office of Management and Budget has approved and released a long-awaited proposed rule on a unique device identification system for medical devices. The document was ...

Recent regulatory reforms to Australia’s medical device framework have shown Australia’s Therapeutic Goods Administration (TGA) a new way of collaborating with industry to make improvements and ensure ...

FDA has announced it has proposed that most medical devices distributed in the United States carry a unique device identifier, according to a news release. The announcement comes in response to ...

EWING, N.J., June 10, 2019 /PRNewswire-PRWeb/ -- GS1, the leading global supply chain standards organization, has been designated by the European Commission as issuing entity for Unique Device ...

A recent blog post in the reSOURCEs section of the HealthTrust public website discusses how the new UDI system will affect healthcare operations. In 2013, the U.S. Food and Drug Administration (FDA) ...