In 1976, following a US Senate finding that faulty medical devices had caused over 10,000 injuries, including 731 deaths, the the Medical Device Amendments defined medical devices and applied safety and effectiveness regulations to new medical devices.

All legal requirements of medical devices are specified in the 800 series of Title 21. This helps ensure that there is no ambiguity about whether a particular object is to be regulated as a medical device.

A medical device, as defined by the FDA is:

“An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

1. recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
2. intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
3. intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.”

In plain speak, a medical device is any object that is used to treat, diagnose, prevent, or reduce the impact of disease or abnormal physical condition but does not do so through chemical means. These can be as simple as an ace bandage or as complex as an MRI machine.

Diagnostic devices are objects that are meant for the identification of disease or disease progression, or other conditions.

Therapeutic devices are objects that are meant for treatment, prevention, or mitigation of diseases or other conditions, or intended to affect the structure or any function of the body of man or other animals through non chemical means.

Learning Objectives:

- 1.1 - Describe the role of the FDA and other regulatory bodies in the manufacturing of medical devices.