What is a Medical Device?
A medical device is “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar article that is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease.” Medical devices can be anything from thermometers to artificial hearts to at- home pregnancy test kits. The FDA reviews and approves devices through investigational studies to see if: • the product does what it claims to do effectively, and • does not present any unreasonable risks to the patient. For more information from the FDA on medical devices please see http://www.fda.
A medical device is any instrument, apparatus, or other similar or related article, including component, part, or accessory, which is: (a) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them; (b) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in humans or other animals; or (c) intended to affect the structure or any function of the human body or in animals; and does not achieve any of its principal intended purposes through chemical action within or on the human body or in animals and is not dependent upon being metabolized for the achievement of its principal intended purposes. Approximately 1,700 types of medical devices are regulated by FDA. The range of devices is broad and diverse, including bandages, thermometers, ECG electrodes, IUDs, cardiac pacemakers, and hemodialysis machines. For further information, see the information sheets entitled
Medical Devices are instruments, appliances, apparatus, materials or other articles including software for the diagnosis, prevention, monitoring, treatment or alleviation of diseases or compensation for injuries or handicaps, investigation, replacement or modification of anatomy or of a physiological process & control of conception.
A “medical device” is defined as a diagnostic or therapeutic article that does not achieve any of its principal intended purposes through chemical action within or on the body. Such devices include diagnostic test kits, crutches, electrodes, pacemakers, arterial grafts, intraocular lenses, and orthopedic pins or other orthopedic equipment.
