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 I devices are low-risk products that have the fewest regulatory requirements. All Class I devices must adhere to General Controls, while a small number of them require Design Controls. Many, but not all, Class I devices can go directly to market with no more than establishment registration and product listing, along with a modest set of quality and labeling requirements.