CFR 21 820.3(c) defines a “component” as “any raw material, substance, piece, part, software, firmware, labeling, or assembly which is intended to be included as part of the finished, packaged, and labeled device”. For example, a stethoscope contains multiple parts, including a diaphragm, bell, and tubing. When packaged in whole with the stethoscope, these parts would be considered medical device components that comprise a finished medical device.
In contrast, FDA clarifies that an “accessory” is a separate, finished device intended to “support, supplement, and/or augment the performance” of at least one parent device. Accessories might be marketed individually for use with a specific device type and may be a different class than their parent device.
For instance, an endoscope, which is used to examine a patient’s internal organs, receives its own medical device classification. An individually marketed endoscopic snare may be attached in order to remove harmful objects from a patient during endoscopy. Because the snare is marketed for intended use with a parent device and it supplements the parent device by adding functionality, the device would likely be considered an accessory.
Likewise, cushions for motorized wheelchairs are often marketed separately with the intent to address specific physiological concerns of the device user. The cushion augments the parent device by improving convenience for the device user. While the motorized wheelchair may be a class II device, the cushion may present lower risk when used with the parent device. Dependent on FDA’s assessment of this risk, the cushion might be considered a class I medical device accessory, subject to different requirements than its parent.
