Unfair and Deceptive Acts and Practices: 2.5.8.4 Medical Devices
The Medical Device Act (MDA), an amendment to the Food, Drug, and Cosmetic Act, explicitly preempts certain state law “requirements” with respect to devices intended for human use.2644 State law requirements are preempted if they relate to the safety or effectiveness of the device or to some other matter included in a requirement applicable to the device under federal law and are different from or in addition to federal requirements.2645 The Supreme Court has held that the term “requirements