Existing clinical data (a) Summary of relevant previous clinical experience with the investigational medical device and with medical devices that have similar characteristics, including such characteristics that relate to other indications for use of the investigational medical device. (b) Analysis of adverse device effects and any history of modification or recall. Risk management (a) Summary of the risk analysis, including identification of residual risks. (b) Result of the risk assessment. (c) Anticipated risks, contra-indications, warnings, etc. for the investigational medical device.