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
- Risk of Eye and Skin Injuries from Hand-held Laser Pointers: FDA Safety Communication (December 22, 2015)
Information on Pediatric Medical Cribs and Medical Bassinets Used in Homes, Child Care Settings and Traditional Health Care Facilities Baby Products with SIDS Prevention Claims Pediatric X-ray Imaging
- FDA’s Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging (2010)
- Consumer Product Safety Commission (CPSC) and FDA Warn Against Using Infant Sleep Positioners Because of Suffocation Risk: Initial Communication (September 2010) [ARCHIVED]
Pediatric Public Workshops and Committees
- Public Workshop – Complex Issues in Developing Medical Devices for Pediatric Patients Affected by Rare Diseases (January 2014) [ARCHIVED]
- Complex Issues in Developing Drugs and Biological Products for Rare Diseases and Accelerating the Development of Therapies for Pediatric Rare Diseases; Including Strategic Plan (PDF - 1.5MB)
This report summarizes the above public workshop and includes a strategic plan to accelerate the development of therapies for rare diseases.
- FDA Office of Orphan Products Development Pediatric Medical Devices Workshop (September 2012)
FDA OOPD Pediatric Medical Devices Workshop, September 24, 2012 Meeting Transcript: Improving the Availability of Pediatric Devices (6/28/04)(TXT - 495KB)
- Pediatric Advisory Committee (PAC)
PAC advises and makes recommendations to the FDA Commissioner regarding pediatric research, identification of research priorities, ethics, design, and analysis of clinical trials, adverse event reports and any safety issues that may occur.
- Safety Reporting Updates Website
This lists products with associated adverse events that have been reported to the PAC and the committee’s recommendations.
- Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices - Guidance for Industry and Food and Drug Administration Staff (June 2016) (PDF - 367KB)
- Providing Information about Pediatric Uses of Medical Devices – Guidance for Industry and FDA Staff (May 2014)
- Premarket Assessment of Pediatric Medical Devices; Guidance for Industry and FDA Staff (March 2014)
- Draft Guidance for Industry and Food and Drug Administration Staff - Pediatric Information for X-ray Imaging Device Premarket Notifications (May 2012)
- Pediatric Expertise for Advisory Panels: Guidance for Industry and FDA Staff (June 2003)
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.
- Report to Congress: Barriers to the Availability of Medical Devices Intended for the Treatment or Diagnosis of Diseases and Conditions that Affect Children (October 2004) (PDF - 101KB)
- FY 2014 Pediatric Report to Congress (PDF - 5.1MB)
FY 2013 Pediatric Report to Congress(PDF - 3.4MB) FY 2012 Pediatric Report to Congress(PDF - 2.4MB)
- FY 2009-2011 Pediatric Report to Congress (PDF - 418KB)
FY 2008 Pediatric Report to Congress(PDF - 968KB)