Pediatric patients as defined by the Center for Devices and Radiological Health (CDRH) are individuals who are younger than 22 years.

• Neonates: from birth → first 28 days of life
• Infants: 29 days to 2 years
• Children: 3 years to 5 and 6 to 11
• Adolescents: 12 through 21 (up to but not including the 22nd birthday)

Source: F.D.A. Clinical Trials for Patient Engagement Advisory Committee