What is a medical device?

The US government has a definition of what a medical device is and this is important to know when your product meets this definition because if it does, you will need to comply with the US medical device regulations.  The definition below is for the United States, but there are similar definitions for European, Asian, and other North/South American countries.

Section 201(h) of the US Federal Food Drug & Cosmetic (FD&C) Act regulated by the Food and Drug Administration (FDA) defines a medical device as:

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

• recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,

• 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

• 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. The term "device" does not include software functions excluded pursuant to section 520(o).

So what are some key takeaways from the above definition?

•  The definition clearly goes out of its way to capture a broad set of terms that could be used to describe a medical device (e.g., implement, machine, contrivance, etc.)
•  Note that the definition includes both "treatment" devices such as those that come in contact with the body (ex. an artificial hip) and "diagnostic" devices that do not contact the body such as a lab test that is used to determine if a person has a disease or not.
•  The definition applies for both human and veterinary medicine
•  The last bullet paragraph is what really distinguishes "medical device" from "drug/pharmaceutical" by stating that the primary intended purpose is not achieved through chemical action.