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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.
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Women’s healthcare device manufacturer CooperSurgical received a Form 483 for failure to initiate corrective action for a process failure associated with its Blunt Hurd Cannula-Blunt Tip 10mm with 5mm Reducer. Read More
While China’s year-old medical device regulations require clinical trials for Class II and Class III devices, there are some defined exceptions and regulators are in the process of finalizing guidance to help companies take advantage of them, an expert says. Read More
The U.S. FDA issued a final rule today placing urethral inserts with pumps to facilitate bladder drainage in Class II with special controls, including biocompatibility testing. Read More
Devicemakers in India that exceed the U.S. FDA’s quality system expectations would receive fewer inspections and other incentives, under a pilot program announced last month. Read More
Lack of progress on medical device reform legislation has spurred some EU countries to use last year’s joint immediate action plan to improve device oversight. Read More
By 2020, the U.S. FDA will update criteria on antibiotic susceptibility testing devices use to guide appropriate antibacterial drug treatment, under an action plan released by the White House on March 27. Read More
The number of medical devices recalled in the U.S. during the final quarter of 2014 increased over the previous quarter despite an overall drop in the number of recall actions, a report from Stericycle Expert Solutions shows. Read More