Investigational medical device and methods 6.1 Investigational medical device description The description of the investigational medical device should contain the following points:— (a) a description of the investigational medical device; (b) the intended use of the investigational medical device(s); (c) previous intended uses or indications for use, if relevant; (d) any changes to the investigational medical device during the clinical investigation or any changes from the IB, including, — Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India (i) raw materials; (ii) software; (iii) components; (iv) shelf-life; (v) storage conditions; (vi) instructions for use; and (vii) other changes. 6.2 Clinical investigation plan (CIP) A summary of the CIP, including any subsequent amendment(s) with a rational for each amendment, should be provided. The summary will include a brief description of the following points:— (a) the clinical investigation objectives; (b) the clinical investigation design including, — (i) the type of clinical investigation; (ii) the clinical investigation endpoints; (iii) the ethical considerations; (iv) the data quality assurance; (v) the subject population for the clinical investigation, with the, — (A) inclusion or exclusion criteria; and (B) sample size; a clear accounting of all participant who entered the clinical investigation shall be mentioned. Mention should also be made of all cases that were dropouts or protocol deviations. Enumerate the patients screened, randomized, and prematurely discontinued. State reasons for premature discontinuation of therapy in each applicable case. (vi) the treatment and treatment allocation schedule; (vii) any concomitant medications / treatments; (viii) the duration of follow-up; (ix) the statistical analysis including— (A) the clinical investigation hypothesis or pass or fail criteria; (B) a sample size calculation; and Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 200 of 248 (C) statistical analysis methods.