A new CDRH draft guidance helps disambiguate the regulation of device accessories by outlining intended application of classification policies and automatic Class III designation.
A device accessory may be classified by 1) inclusion in its parent device’s classification order, 2) its own 510(k) premarket notification or PMA approval in the same class as its parent device, or 3) through a separate classification process seeking a class different from its parent device. With regard to these first two methods, the FDA states, “Classifying an accessory in the same class as its parent device is appropriate when the accessory, when used as intended, meets the criteria for placement in that class.” For accessories that do not pose the same level of risk as their parents, however, the FDA encourages separate classification.
Accessories with substantially equivalent predicate devices can, of course, seek assignment to Class I or II independent of their parent device through the 510(k) pathway. New types of accessories seeking to be regulated as Class I or II, however, must utilize the de novo pathway to avoid automatic Class III designation. The draft guidance describes the applicability of the de novo process to accessories and includes an appendix of information, such as proposed controls, that manufacturers should include in these de novo requests for accessory device classification.