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The South Korean government has drafted a regulation that would expand its medical device tracking system to include 24 additional types of products. Read More
Margaret Hamburg has resigned as commissioner of the U.S. FDA, effective at the end of this month, ending a six-year tenure that saw the agency speed up its device approval process and increase its focus on personalized medicine. Under Hamburg’s watch, the agency’s budget rose by nearly $2 billion — from $2.7 billion in fiscal year 2009 to $4.5 billion this year. Read More
Devicemakers seeking to register products in South Korea say new regulations requiring them to first obtain a Korean good manufacturing practice certificate could delay product launches. 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
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.
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The FDA’s Neurological Devices Panel will meet April 17 to discuss clinical trial considerations for flow diverters that are intended to treat brain aneurysms. Read More