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Class III and IV medical devices produced using additive manufacturing “require a review of submitted evidence of safety and effectiveness before a license can be issued,” the agency said. Read More
The FDA disagreed with OIG’s conclusions that the lack of a formal arrangement with federal partners hurts information flow about cybersecurity. Read More
The FDA granted an emergency use authorization (EUA) for a single-use, rapid fingerstick test for the Ebola virus, only the second test of its kind made available under an EUA. Read More
The International Medical Device Regulators Forum (IMDRF) has released final guidances on optimizing standards for regulatory use, essential principles of safety and performance, and definitions for personalized devices. Read More
The European Commission added four new products it considers devices to its Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices, including several related to contraception. Read More
China’s State Drug Administration is implementing a new device review procedure to bring innovative devices to market faster and to encourage more innovation in China’s supply chain. Read More