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Canada’s Medical Technology Companies association said it strongly supports the Canadian government’s plans to change the country’s complex regulatory, reimbursement and procurement process for medtech. Read More
The agency revised the terms after the improper use of single-dose containers led to the transmission of bacterial and viral infections in multiple patients. Read More
The FDA issued final guidance on “single-dose” and “multiple-dose” containers for injectable medical products — introducing a new term “single-patient use.” Read More
Boston Scientific and Cook Medical questioned parts of the FDA’s guidance on premarket notifications for metal expandable biliary stents and their delivery systems — including limits on eligibility for the Special 510(k) program and some recommended test methods in the agency’s draft released in July. Read More
The FDA needs to do more to ensure the cybersecurity of networked medical devices, according to a new report from the HHS Office of Inspector General. Read More