Class II—Special Controls

Class II27 devices are those for which general controls alone are insufficient to assure safety and effectiveness, and existing methods are available to provide such assur­ances. In addition to complying with general controls, Class II devices are also subject to special controls. Note, a few Class II devices are exempt from the premarket notification.28

Special controls may include special labeling requirements, mandatory performance standards, and postmarket surveillance. Examples of Class II devices include oxygen masks,29 artificial eyes,30 and other devices that do not by themselves maintain life, such as powered wheelchairs, infusion pumps, surgical drapes, x-ray machines, and tampons. Laser and light-based systems used in cosmetic dermatology are also Class II medical devices.

Updated: September 29, 2015 — 9:40 pm