From the point of view of the U.S Food and Drug Administration (FDA), a medical device may be defined as an apparatus, instrument, in vitro reagent, implant or any other similar or associated article including an accessory or even component part that is:
- Recognized in the United States Pharmacopoeia, the Official National Formulary, or any supplement to them.
- Meant for making a diagnosis of disease or other conditions, or in the prevention, mitigation, treatment or cure of disease, in human beings or other animals.
- Meant to affect any function or structure in the body of human beings or other animals, and which does not accomplish any of its principal intended objectives by way of chemical action on or within the body of human beings or other animals and which does not require its being metabolized to accomplish any of its key intended objectives
In contrast to medical devices that work by physical, thermal or mechanical means, pharmaceuticals or medicinal products achieve their key objectives by metabolic, pharmacologic or immunological means.
Medical Devices – Some Examples
A medical device can be something as simple as a bedpan or as complicated as a laser surgical device. Other commonly used devices include wheelchairs, orthopedic pins, intraocular lenses and pacemakers. The term also incorporates in vitro diagnostic products including general purpose lab equipment, test kits for in vitro diagnosis (IVD) of pregnancy, disease or other conditions, and reagents. In addition, some kinds of products which emit electronic radiations for medical applications also come under the term “medical device.” X-ray machines, diagnostic ultrasound products and medical lasers are some examples for this.
Medical device packaging is greatly regulated. Frequently, such kind of devices is sterilized in its packaging. Sterility has to be kept up all through the distribution process to enable the physician to immediately use it.