Minneapolis Firefighters' Relief Association V Medtronic, Inc 3488 Form

Instructions and help about Minneapolis Firefighters' Relief Association V Medtronic, Inc 3488

in 1976 congress passed the medical device amendments to the federal food drug and cosmetics act the amendments provided for federal safety oversight of the introduction of new medical devices to the market the amended statute also contained a preemption provision prohibiting states and municipalities from imposing any requirements relating to a medical device's safety or effectiveness that differed from or added to any of the federal requirements for the device in regal versus medtronic the court analyzed whether the statute preempted state tort claims alleging that a federally approved medical device was defective the medical device amendments group devices into classes for federal oversight purposes depending on the risks presented by the devices class iii devices are the riskiest they're put through a rigorous pre-market approval process in which the device's manufacturer must reasonably assure the food and drug administration or fda that the device is safe and effective the agency