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 sponso ...

Preventive action: The manufacturer shall determine action to eliminate the causes of potential non-conformities in order to prevent their occurrence. Preventive actions shall be appropriate to the effects of the potential problems. A documented procedure shall be established to define requirements for-— (a) determining potential non-conformities and their causes, (b) evaluating the need for a ...