Overall synopsis of the clinical investigation A summary or overview of the clinical investigation shall include all the relevant information regarding clinical investigation design such as inclusion or exclusion criteria, number of subjects, duration of clinical investigation, follow-up, objective and endpoint. 1.2 Identification and description of the investigational medical device (a) Summary description of the investigational medical device and its intended purpose. (b) Details concerning the manufacturer of the investigational medical device. (c) Name or number of the model or type, including software version and accessories, if any, to permit full, identification. (d) Description as to how traceability shall be achieved during and after clinical investigation, for example by assignment of lot numbers, batch numbers or serial numbers. (e) Intended purpose of the investigational medical device in the proposed clinical investigation. (f) The populations and indications for which the investigational medical device is intended. (g) Description of investigational medical device including any materials that will be in contact with tissues or body fluids. (This shall include details of any medicinal products, human or animal tissues or their derivatives, or other biologically active substances.) (h) Summary of the necessary training and experience needed to use the investigational medical device. Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 182 of 248 (i) Description of the specific medical or surgical procedures involved in the use of investigational medical device. 1.3 Justification for the design of the clinical investigation Justification for the design of clinical investigation, which shall be based on conclusions of the evaluation, and shall comprise a section on justification for the design of the clinical investigation and include— (a) an evaluation of the results of the relevant pre-clinical testing or assessment carried out to justify the use of investigational medical device in human subjects; and (b) an evaluation of clinical data that are relevant to the proposed clinical investigation.