What is a Medical Device?
Medical Device Definition
A medical device is defined within the Food Drug & Cosmetic Act as “…an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of it’s primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.”
Dangerous or defective medical devices — such as faulty surgical instruments, implants, pacemakers, and prosthetics can give rise to a product liability claim if a person who undergoes surgery or uses a medical device is injured or dies as a result. Although closely monitored by the U.S. Food and Drug Administration (FDA), a product can be defective in its design, manufacturing process, or marketing strategy. In most instances, state lawsuits over federally-approved medical devices face stringent legal obstacles and often receive increased national attention. Below, you will find resources that highlight common high-risk medical devices such as stents and defibrillators, and links to product liability lawyers in your area, as well as helpful forms and other resources.