Generic type of device

Each US classification regulation describes one generic type of device and its class. A new device is placed by finding the generic type that matches it.

Generic type of device means a grouping of devices that do not differ significantly in purpose, design, materials, energy source, function, or any other feature related to safety and effectiveness, and for which similar regulatory controls are sufficient to provide reasonable assurance of safety and effectiveness.

21 CFR, 860.3