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Sen. Patrick Leahey (D-Vt.) effectively killed any chance at patent reform legislation by removing H.R. 1720 from the agenda of the Senate Finance Committee, which he chairs. 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
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
Argentina’s ANMAT has adopted strict traceability requirements for medical devices, with the aim of stemming the flow of counterfeit products. Read More
Only devices that violate the 1938 FD&C Act should be labeled Import for Export, FDA officials cautioned at the recent FDA/Xavier University MedCon conference. Read More
The China Food and Drug Administration received nearly 239,000 reports of device adverse events in 2013, with overall quality of adverse event reporting improving, the agency said earlier this month. Read More
Overall reports of adverse events declined over the past three years from 21,729 in 2011 to 14,819 in 2013, according to data published by the UK’s Medicines and Healthcare products Regulatory Agency. Read More
The U.S. Food and Drug Administration may approve devices whose benefit-to-risk ratio is less certain if that uncertainty is “sufficiently balanced” by factors such as postmarket controls, the agency says in an April 23 draft guidance. Read More
Argentina’s ANMAT has adopted strict traceability requirements for medical devices, with the aim of stemming the flow of counterfeit products. Read More