FDA is responsible for the regulation of various products including medical devices. FDA's primary responsibility is to ensure the safety and effectiveness of the products it regulates. In determining what regulations apply to a particular product, the analysis first begins with whether the product falls within the definition of a medical device.
The Food Drug and Cosmetic Act 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 any of 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 any of its primary intended purposes.
FDA has classified over 1,700 different types of devices. These classifications include Class 1, Class 2, Class 3, and unclassified.
Class 1 medical devices are traditionally those medical devices that pose little risk, such as a toothbrush. Most of these devices do not require a premarket application. Registration and device listing are required.
Most Class 2 devices require premarket notification in the form a 510K application.
Class 3 devices are those devices that require additional oversight, such as life-sustaining devices. These devices require premarket approval through an application traditionally referred to as a PMA.