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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
The FDA and the Department of Homeland Security signed a memorandum of agreement that expands their collaboration for medical device cybersecurity. Read More
Three Democratic senators raised concerns about the FDA’s digital health pre-certification program and called for more details from the agency. Read More
To give a reasonable assurance of safety and efficacy of high flow humidified oxygen delivery devices, the FDA reclassified them into Class II and identified special controls. Read More