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