class III device

A highly-regulated ‘high risk’ medical device—e.g., pacemakers and heart valves—approved by the FDA for use in humans

class III device

Regulatory affairs A highly regulated 'high risk' medical device–eg, life-support or life-sustaining devices–eg, pacemakers and heart valves, approved by the FDA for use in humans; CIIIDs are also defined as those which pose a potentially unreasonable risk of illness or injury. See Medical device.