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U.S. and European diabetes groups are recommending that an international registry be established to gather reports on insulin pump safety, citing lax EU device regulations that leave patients at risk. Read More
The FDA recently ordered drugmakers in the $1.6 billion testosterone-replacement therapy market to update their labels with warnings of the potential for increased heart attack risks when used for aging-related low testosterone. Read More
The U.S. FDA has chosen a veteran public health officer to spearhead its device postmarket surveillance programs. Gregory Pappas joined the agency in February as associate director for national device surveillance in the Center for Devices and Radiological Health’s Office of Surveillance and Biometrics. Read More
The U.S. FDA will roll out a simplified adverse event reporting form this spring in hopes of getting more consumers to use its MedWatch system, agency officials said Feb. 4. Read More
U.S. industry group AdvaMed is working with regulators around the world to ensure a global approach to unique device identification — to avoid scenarios where different countries’ UDI systems can’t communicate with one another. Read More
Beginning Jan. 26, labelers of implantable, life-supporting and life-sustaining devices that are not Class III can register with the FDA’s Global Unique Device Identification Database. Labelers of all other Class II devices are to request GUDID accounts later in 2015, the agency said. Read More
Patient registries are contributing significant data on the safety and effectiveness of implanted devices, and with the advent of the FDA’s unique device identification system, it is now possible to link implant characteristics to the Global UDI Database, a recent study suggests. Read More