Pediatric medical devices treat or diagnose diseases and conditions from birth through age 21. 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:
- 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.
FDA Safety Communications
FDA Pediatric Resources
Information on Medical Cribs Used in Homes and Child Care Settings Berlin Heart EXCOR® Pediatric Ventricular Assist Device (VAD) - H100004[ARCHIVED] Pediatric X-ray Imaging Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging Draft Guidance for Industry and Food and Drug Administration Staff - Pediatric Information for X-ray Imaging Device Premarket Notifications Baby Products with SIDS Prevention Claims
- Premarket Assessment of Pediatric Medical Devices; Guidance for Industry and FDA Staff
Pediatric Expertise for Advisory Panels; Guidance for Industry and FDA Staff
- FDA Office of Pediatric Therapeutics
- FDA Information about Pediatrics
- Report to Congress: Barriers to the Availability of Medical Devices Intended for the Treatment or Diagnosis of Diseases and Conditions that Affect Children (PDF - 101KB)
Meeting Transcript: Improving the Availability of Pediatric Devices (6/28/04)(TXT - 495KB) Federal Register: Possible Barriers to the Availability of Medical Devices Intended for the Treatment of Diagnosis of Diseases and Conditions that Affect Children (Docket #2004-0254) Public Comments to FR Docket #2004-0254 (PDF)(PDF - 7.6MB)
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.