Device

Something developed by the application of ideas or principles that are designed to serve a special purpose or perform a special function.


An item or piece of equipment used in the healing arts that is not a drug. Device is defined in the Federal Food, Drug, and Cosmetic Act as including instruments, apparatus and contrivances, including their components, parts and accessories, intended : for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; or to affect the structure or any function of the body of man or other animals. Among the products that are regulated as devices are crutches, bandages, wheelchairs, artificial heart valves, cardiac pacemakers, intrauterine devices, eye glasses, hearing aids, and prostheses. The term device will be broadened and clarified in legislation that is now pending in Congress. The proposed definition of device will still make it clear that what distinguishes a device from a drug is that a device does not achieve any of its principal intended purposes through chemical action within or on the body and is not dependent on being metabolized for the achievement of any of its principal intended purposes. The proposed legislation will also provide new detailed authority for regulation of the marketing of devices which, properly used, will assure that devices are safe and effective.


An apparatus or item used for diagnosis, treatment, or prevention of disease, which does not achieve its purpose through chemical action on or within the body (to distinguish it from a drug). Examples of devices include artificial heart valves, cardiac pacemakers, prostheses, hearing aids, crutches, and wheelchairs. The federal Food and Drug Administration (FDA) regulates devices to assure that they are safe and effective.


An apparatus, machine, or shaped object constructed to perform a specific function.


 


Posted

in

by

Tags: