A device is an instrument, apparatus, implant, or other similar article that is used in the prevention, diagnosis, or treatment of illness or disease, or for detecting, measuring, restoring, correcting, or modifying the structure or function of the human or animal body for a health purpose. Devices do not rely on metabolism or any other chemical action for their primary intended purpose.
Devices are assigned to one of three regulatory classes (I, II, or III) based on the level of control necessary to assure the safety and effectiveness of the product. The amount of risk the device poses to a patient and/or user plays a major factor in the determination of its class. It is necessary to define the product’s intended use and indications for use to determine whether you have a medical device and for device classification. For more information, visit: https://www.fda.gov/medical-devices/classify-your-medical-device/how-determine-if-your-product-medical-device.
Class III devices pose the highest level of risk to patients and/or users. These devices support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential, unreasonable risk of illness or injury. Hence, these devices are subject to a much higher level of scrutiny by the FDA. For class III devices, device companies are required to file a premarket approval (PMA) application to evaluate their safety and effectiveness and to obtain FDA approval for commercial distribution.