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A sweeping rewrite of Canada’s drug safety law that authorizes the government to order recalls and require labeling changes and postmarket studies could spell new worries for devicemakers because it also allows for the release of confidential business information on unsafe products. Read More
Labeling and packaging errors and software problems accounted for more than 40 percent of medical device recalls during the 2014 third quarter, according to compliance company Stericycle. Read More
The FDA is revising an August final guidance on design considerations for home use devices to reflect growing concerns about power outages and the potential for electromagnetic disturbances. Read More
Hospira is recalling all of its GemStar Power Supply 3VDC units, used to power the GemStar Infusion Pump, because they may fail to deliver electric power to the pump. Read More
The European Commission is again seeking input on the risks associated with di(2-ethylhexyl) phthalate plasticized PVC in medical devices, saying more data is needed before banning its use. Read More
A sweeping rewrite of Canada’s drug safety law that authorizes the government to order recalls and require labeling changes and postmarket studies could spell new worries for devicemakers because it also allows for the release of confidential business information on unsafe products. Read More