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 II devices are moderate-risk products that must adhere to General Controls. Although they have greater risk than Class I devices, the risks can be mitigated to an acceptable level by assuring the product meets certain performance standards or requirements, called Special Controls. Those who want to market a Class II device intended for human use, will need to file a premarket notification with the FDA, also known as a 510k submission. Each submission also requires the identification of an already marketed predicate product to which the new device must show Substantial Equivalence. Once a Class II device receives FDA clearance, the product can be distributed commercially.
Under certain circumstances, a device may not be subject to the above requirements. Specifically, a device may be exempt if it meets the following criteria: it is noninvasive, it does not require an invasive sampling procedure that poses significant risk, it does not introduce energy into a subject by design, and it is not intended for use in diagnostic procedures. For more information on investigational device exemption (IDE), visit: https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/investigational-device-exemption-ide.