Pediatric patients

FDA's definition reaches up to age 21, older than many people expect, so a device used in young adults may have pediatric use. PMA applicants have to describe the pediatric subpopulations that suffer from the disease the device is meant for.

Pediatric patients means patients who are 21 years of age or younger (that is, from birth through the twenty-first year of life, up to but not including the twenty-second birthday) at the time of the diagnosis or treatment.

21 CFR, 814.3