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Pediatric Medical Devices

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Pediatric medical devices treat or diagnose diseases and conditions from birth through age 21. The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines pediatric patients as persons aged 21 or younger at the time of their diagnosis or treatment. Pediatric subpopulations are further categorized as follows:

  • Neonates - from birth through the first 28 days of life
  • Infants - 29 days to less than 2 years
  • Children - 2 years to less than 12 years
  • Adolescents - aged 12 through 21 (up to but not including the 22nd birthday)

Some products are designed specifically for children, while others are borrowed from adult applications or produced for more general use. Designing pediatric medical devices can be challenging: children are often smaller and more active than adults, body structures and functions change throughout childhood, and children may be long-term device users -- bringing new concerns about device longevity and long-term exposure to implanted materials.

FDA is committed to supporting the development and availability of safe and effective pediatric medical devices. Current initiatives include:

  • Increasing the number of medical devices with labeling for pediatric patients by incorporating known information about device effects in other populations to support pediatric indications.
  • Recruiting pediatric experts for FDA advisory panels whenever there is a reasonable likelihood that the device under discussion will be used for children.
  • Protecting children who participate in clinical trials.
  • Collaborating with the Institute of Medicine on the effectiveness of post-market surveillance of pediatric medical devices.
  • Collecting data on the unmet needs for pediatric medical devices and the barriers to the development of new pediatric devices.

On this page, you will find various information and resources about pediatric medical devices and pediatric device initiatives at the FDA.

Pediatric Device Safety Information

Pediatric Public Workshops and Committees

Guidance Documents

Pediatric Device Development

Reports to Congress

Each year, the FDA reports on recently cleared or approved devices for pediatric use, and on the agency’s activities in the areas of research, publications, public workshops and website development for promoting and developing safe and effective pediatric devices.

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