Pediatric Medical Devices
UPDATE: June 15, 2026
On June 15, 2026, the FDA issued a Warning Letter to the manufacturer of the SNOO Smart Sleeper (SNOO), Happiest Baby, Inc., for a number of violations, including selling new sleep sack sizes and hospital SNOO bassinet bundles without first undergoing FDA review and obtaining FDA authorization. The FDA strongly cautions patients, caregivers and health care providers that the X-Small and X-Large sleep sacks, and the SNOO Hospital Bundle, have not been evaluated for safety and effectiveness by the FDA and pose increased risks as described in the Warning Letter. The FDA also cautions that stains, soiling and unsanitary conditions have been reported on refurbished SNOOs distributed to customers, which may pose risk of infection. The FDA also cautions that mold has been reported on SNOO Smart Sleeper mattresses and/or mattress covers.
The FDA will continue to keep the public informed if new or additional information becomes available. For reporting injuries, malfunctions, unsanitary, or poor quality issues related to the SNOO products above, we encourage users to report the problem through the MedWatch Voluntary Reporting Form.
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
- Do Not Use Baby Neck Floats Due to the Risk of Death or Injury: FDA Safety Communication
- Potential Risk of Strangulation in Children Who Use Enteral Feeding Delivery Sets - FDA Safety Communication
- FDA Warns Against Use of Teething Necklaces, Bracelets, and Other Jewelry Marketed for Relieving Teething Pain or Providing Sensory Stimulation: FDA Safety Communication
- What Does A Safe Sleep Environment Look Like
- 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)
Pediatric Public Workshops and Committees
- Public Meeting - Pediatric Medical Device Development - August 13-14, 2018
- FDA Office of Orphan Products Development Pediatric Medical Devices Workshop (September 2012) [Archived]
- Meeting Transcript: Improving the Availability of Pediatric Devices (6/28/04)
- Pediatric Advisory Committee (PAC)
- Safety Reporting Updates Website
Guidance Documents
- 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) (PDF - 177KB)
- Premarket Assessment of Pediatric Medical Devices; Guidance for Industry and FDA Staff (March 2014) (PDF - 162KB)
- Pediatric Expertise for Advisory Panels: Guidance for Industry and FDA Staff (June 2003)
Pediatric Device Development
- Pediatric Device Consortia Grant Program
- 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 received to FR Docket #2004-0254 (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.
- FY 2022-2023 Pediatric Report to Congress (PDF - 725KB)
- FY 2021 Pediatric Report to Congress (PDF - 409KB)
- FY 2019-2020 Pediatric Report to Congress (PDF - 839KB)
- FY 2018 Pediatric Report to Congress (PDF - 776KB)
- FY 2017 Pediatric Report to Congress (PDF - 242KB)
- FY 2016 Pediatric Report to Congress (PDF - 199KB)
- FY 2015 Pediatric Report to Congress (PDF - 234KB)
- 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)
- FY 2014 Pediatric Report to Congress
- FY 2013 Pediatric Report to Congress
- FY 2012 Pediatric Report to Congress
- FY 2009-2011 Pediatric Report to Congress
- FY 2008 Pediatric Report to Congress