Definition of a Medical Device

A device can range from simple to very complex and must not fit any of the properties that would be better suited as a definition of a drug. A drug would be activated by a chemical interaction with the skin or need to be metabolized.

Classification of a medical device depends upon its intended use. The device can be classified as a Class I, Class II or a Class III device. Class I devices are considered low-risk devices and require only general controls. Devices that have a medium to moderate risk are considered a Class II device and has additional special controls placed upon it. If a device is considered a life-supporting and/or life-sustaining device, it is classified as high risk and would be classified a Class III.

The thing to watch is what is coming out (information, directives, guidance, etc.) of the newly formed FDA Office of Combination Products as this will determine if a firm’s product will be regulated more like a device or a drug. This will then tell the firm which set of FDA regulations to which they must adhere.