who ensures safety of medical devices
New EU rules to ensure safety of medical devices. Brussels, 5 April 2017. Ranging from simple contact lenses and sticking plasters to sophisticated pacemakers and hip replacements, medical devices and in vitro diagnostic medical devices are important to our health and quality of life.
FDA's mandate is to ensure safety and efficacy of all products it regulates, in contrast to some other regulatory agencies, which are concerned mainly with safety. For devices that go through the PMA approval pathway, FDA is evaluating each device for safety and efficacy on its own terms.