FDA Definitions

The Food and Drug Administration uses the following definitions when reviewing and regulating products.

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.

Radiation-emitting products include: such things as microwave ovens, televisions, sunlamps, medical and baggage inspection x-ray machines, lasers, CT/MRI scans, diagnostic ultrasound, laser light shows and bar code scanners.

Before granting approval to manufacturers to sell their new devices, FDA science experts review the manufacturer’s data from investigational studies to see if:

• the product does what it claims to do effectively, and
• does not present any unreasonable risks to the patient.