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Health Canada will issue manufacturers a list of medical devices associated with active medical device licenses and give them the opportunity to determine the 5-digit GMDN code for their devices. Read More
The European Commission provided further guidance for devicemakers on how to distinguish borderline devices and in vitro diagnostics in a new Version 1.19 of its manual on… Read More
The rejection “reflects the agency’s belief that the current processes in place at servicing facilities support continued quality, safety, and effectiveness of medical devices that undergo servicing,” the agency said. Read More
Clinical trial sponsors must step up their efforts to address underrepresentation of women among subjects in clinical trials, including for medical devices, said FDA Commissioner Scott Gottlieb during a meeting to commemorate National Women’s Health Week. Read More
Industry leaders are calling on Congress to modernize legislation covering clinical laboratory diagnostics to bring it into the 21st Century. Read More