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The FDA recently highlighted a number of devices approved and cleared for marketing by its Office of Device Evaluation in 2005 that "will have a particular impact on patient care."
The time and expense required to get an FDA premarket approval (PMA) for a device may be worth it, as some devicemakers are finding themselves in court after taking the more streamlined 510(k) approval route, compliance lawyers say.
Health Canada’s Health Products and Food Branch (HPFB) eliminated 80 percent of its backlog of medical device submissions in 2005, according to the agency’s 2005 Annual Summary of Performance.
Health Canada’s Therapeutic Products Directorate (TPD) is undertaking a series of actions aimed at improving the agency’s processing and review of new medical devices and pharmaceuticals seeking access to the Canadian marketplace.
The FDA believes that its ongoing efforts to improve postmarket drug reviews are sufficient to address perceived flaws in the agency’s drug review procedures, a key agency official says.