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The FDA is clarifying language related to the direct marking of medical devices for unique device identification purposes, including the definition of reprocessing. Read More
Devicemakers looking to get new products on the market should prepare to shell out more money in fiscal year 2016, as user fees for all types of applications are rising. Read More
French health officials have promised to beef up surveillance of medical devices as part of a multi-year action plan released late last month. Read More
A group of former U.S. lawmakers is encouraging Congress to remove barriers to accelerating the development of medical devices for unmet needs. Read More
A bipartisan group of U.S. senators is hoping to ease access to innovative devices for Medicare patients through the creation of self-pay arrangements with their healthcare providers. Read More
With surgeons using robotically assisted surgical devices in new ways, the FDA wants more information on how to best assess these tools to ensure the safety of patients while enhancing innovation. Read More
Members of the World Trade Organization have signed a $1.3 trillion trade deal that would eliminate tariffs on more than 200 information technology products, including pacemakers and other essential medical devices. Read More
Patient labeling for medical devices will take center stage at a September FDA workshop as the agency considers updating industry guidance on the topic. Read More