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 ...
Opportunities exist in enhancing medical device labeling systems, focusing on clear instructions and compliance with regulatory requirements. Leveraging digital solutions like electronic labeling and ...
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 ...
Medical device manufacturers looking to comply with the US Food and Drug Administration's (FDA) new Unique Device Identification (UDI) rule will now have a second accrediting agency from which to ...
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 ...
The US Food and Drug Administration (FDA) last week granted a third extension for soft contact lens labelers yet to comply with the requirements of the Unique Device Identification (UDI) system ...
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 ...
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 ...
Device makers have argued for years that not all medical device recalls are the same, and thus the FDA should be more forthcoming with the public about the difference between a recall that is ...
(MENAFN- GlobeNewsWire - Nasdaq) Opportunities exist for enhancing medical device safety and compliance through improved labeling that meets regulatory standards. These include employing clear ...
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