The use of medical devices is intended to achieve the following intended purposes:
1. Prevention, diagnosis, treatment, monitoring, and alleviation of disease.
2. Diagnosis, treatment, monitoring, alleviation, and compensation for injury or disability.
3. The study, substitution, regulation, or support of anatomical or physiological processes.
4. Support or maintenance of life.
5. Pregnancy control.
6. Providing information for medical or diagnostic purposes through the examination of samples from the human body.
Medical devices are instruments, equipment, apparatus, in vitro diagnostic reagents and calibrators, materials, and other similar or related items used directly or indirectly in the human body, including required computer software.
Medical devices include medical equipment and medical consumables.
Utility is obtained primarily by physical and other means, not by pharmacological, immunological or metabolic means, or is involved but only in an ancillary manner.
Purposes are the diagnosis, prevention, monitoring, treatment, or alleviation of disease; the diagnosis, monitoring, treatment, alleviation, or functional compensation of injury; the examination, replacement, regulation, or support of physiological structures or processes; the support or maintenance of life; the control of pregnancy; and the provision of information for medical or diagnostic purposes through the examination of samples from the human body.