Include the class of the device, (i. e., Class I, II, or III). If the device has not been classified, the fact needs to be mentioned. If known, include the appropriate classification panel, for example, anesthesiology or orthopedics.117 If the device does not have a classification panel, state how this was determined. For example, the manufacturer may state that the device was not listed in the classification regulations, nor was it listed in the related FDA publication.
In most cases, an accessory to a classified device takes on the same classification as the parent device. Software and other accessories that accept input from multiple devices usually take on the classification of the parent device with the highest risk.