Preclinical testing Summary of preclinical testing that has been performed on the investigational medical device, together with an evaluation of results of such testing justifying its use in human subjects. The summary shall include or, where applicable, refer to the results of: (a) design input and design output documents, (b) in vitro tests, (c) mechanical and electrical tests, (d) reliability tests, (e) validation of software relating to the function of the device, (f) any performance tests, (g) ex vivo tests, and (h) biological safety evaluation. 4. 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. 5. 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. Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 180 of 248 6. Regulatory and other references (a) List of International Standards, if any, complied with in full or in part. (b) Statement of conformity with national regulations, where appropriate. (c) List of references, if relevant.