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All devicemakers holding CE certificates for Class IIa medical devices and higher should be prepared for unannounced quality system visits by notified body inspectors. Read More
Massachusetts-based Fresenius Medical Care North America has issued two voluntary recalls of a concentrate used in dialysis machines over fears of bacterial contamination, the FDA said. Read More
Routine quality system surveillance inspections of foreign devicemakers increased by 93 percent in 2012, according to newly released FDA data. Overall QS inspections were up 37 percent for the year. Read More
CooperVision’s Puerto Rico facility has received an FDA warning letter for inadequate investigations into nonconformities and other GMP issues. Read More
BALTIMORE — Devicemakers in the process of setting unique device identification codes with the FDA may want to bake in some extra time, agency officials say. Read More
Medicare spent a total of $1.9 billion in 2009 on 26 different tests and procedures that offered little or no health benefit, according to a new report by researchers at Harvard University, who found that a quarter of Medicare recipients received at least one of the services. Read More