Post Marketing Clinical Investigation: Post marketing clinical investigation is the study other than surveillance performed after marketing approval has been given to the medical device in relation to the approved indication. This investigation may not be considered necessary at the time of medical device approval but may be required by the Central Licensing Authority for optimizing the intended use of the medical Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 170 of 248 device. Post Marketing Clinical investigation includes additional drug device interaction, safety studies, investigation designed to support use under the approved indication e.g. mortality or morbidity studies, etc. (9) Studies in special populations: The clinical investigation data of the medical device is required to be submitted to support the claim sought to be made for use of medical device in children, pregnant women, nursing women, elderly patients with renal or other organ system failure as given below:— (i) Geriatrics: Geriatrics patients can be included in pivotal study (and in pilot study at the sponsor's option) in meaningful numbers, if— (a) the disease intended to be treated is characteristically a disease of aging; or (b) the population to be treated is known to be included in substantial numbers of geriatric patients; or (c) there is specific reason to expect that conditions common in the elderly are likely to be encountered; or (d) the investigational medical device is likely to alter the geriatric patient's response in regard to safety or performance compared with that of non-geriatric patient.