FDA Definition of a Device
A device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory. It is recognized in the official National Formulary, or the U.S. Pharmacopeia, or any supplement to them. It is intended for the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or the diagnosis of conditions other than diseases such as pregnancy, to affect the structure or any function of the body of man or other animals.
- an integral and subordinate part of a procedure
- used for one patient only
- surgically implanted or inserted
- remain with that patient after the patient is released
Devices are not:
- equipment, instruments, apparatuses, implements or such items for which depreciation and financing expenses are recovered
- materials and supplies such as sutures, clips, or customized surgical kits furnished incident to a service or a procedure.
- materials such as biologicals or synthetics that may be used to replace human ski
More About Devices
Questions to Raise Patients' Understanding
Gerald Hickson, M.D., and James Pichert, PhD., have provided this list of questions, which they said are critical for potential subjects to ask. Give this list to potential subjects and expand it to ensure they get the information they need to make informed choices