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 ...

On July 25, 2022, the U.S. Food and Drug Administration (FDA) issued final guidance on Unique Device Identification (UDI) compliance date policies, stating that the agency will not enforce a ...

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.

Please provide your email address to receive an email when new articles are posted on . The FDA is granting an extension for soft contact lens labelers to comply with the requirements of the Unique ...

While the fate of the ACA hangs in the balance, one thing in healthcare is certain: patient safety and quality of care will continue to drive change in the US healthcare market. UDI regulations ...

SANTA BARBARA, Calif.-- (BUSINESS WIRE)-- QAD Inc. (NASDAQ:QADA) (NASDAQ:QADB), a leading provider of enterprise software and services, today announced the enhanced traceability framework in QAD ...

With the deadline approaching for Class II medical devices to comply with unique device identifier regulations, the Food and Drug Administration is focused on ensuring that its infrastructure can ...

SAN FRANCISCO, Nov. 15, 2018 /PRNewswire/ -- Innovit, a global master data management solutions provider, today announced its continued commitment to medical device manufacturers on their journey to ...

Under the FDA's newly enacted UDI rule, devices must be shipped with a unique identification label. (Click to expand.)--Courtesy of the FDA "Mr. UDI" gave industry advice on complying with the complex ...

Starting in September, class II medical devices will be required to be equipped with a unique device identifier to be in compliance with UDI regulations. The U.S. Food and Drug Administration passed ...

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 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 ...