A Medical Device is any article or healthcare product intended for use in the diagnosis of disease or other condition, or for use in the care, treatment or prevention of disease, which does not achieve any of its primary intended purposes by chemical action or by being metabolized.
Medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers with microchip technology and laser surgical devices. In addition, medical devices include in vitro diagnostic products, such as general purpose lab equipment, reagents, and test kits, which may include monoclonal antibody technology. Certain electronic radiation emitting products with medical application and claims meet the definition of medical device. Examples include: diagnostic ultrasound products, x-ray machines and medical lasers. If a product is labeled, promoted, or used in a manner that meets the following definition in section 201(h) of the Federal Food Drug & Cosmetic (FD&C) Act it will be regulated by the Food and Drug Administration (FDA) as a medical device and is subject to pre-marketing and post-marketing regulatory controls. A device is: an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article.
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