Paediatrics: (a) The timing of pediatric studies in the medical device development program shall depend on the device, the type of disease being treated, safety consideration, and the safety and effectiveness of available treatment. (b) The medical device expected to be used in children; the performance and safety shall be made in the appropriate age group. When clinical investigation is required to be conducted in children, it is usually appropriate to begin with older children before extending the investigation to younger children and then infants. (c) If the medical device is predominantly or exclusively used in paediatric patients, clinical investigation data should be generated in Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India. paediatric population except for initial safety and performance data, which will usually be obtained in adults unless such initial safety studies in adults would yield little useful information or expose them to inappropriate risk.