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.