FDA generally determines classification of accessories in one of two ways. An accessory may be included in the same classification as its parent device through 510(k) Premarket Notification, Premarket Application, or express inclusion in the classification regulation of the parent device. Other cases may involve the issuance of a separate classification regulation when FDA considers an accessory to have a different level of risk than its parent device.
The FDA Reauthorization Act of 2017 allows for the classification of accessories based upon the level of risk posed when used as intended and the level of regulatory controls necessary to provide reasonable assurance of safety and effectiveness. Manufacturers may now submit an Accessory Classification Request to FDA to receive appropriate classification of their device accessory. An Accessory Classification Request includes a proposal to FDA that, among other aspects, identifies the accessory, the proposed class of the accessory, and the necessary information to establish the risk the accessory poses.
Medical device classification serves an important role in deciding a device’s FDA requirements, such as the premarket processes it may be subject to or when it is required to comply with certain regulations. Lower device classes may even receive exemption from certain premarket requirements.
