Medical devices are critical tools for the diagnosis and management of disease in children. Unfortunately, very few devices are developed, tested, and approved specifically for kids. Pediatric device innovation lags up to 10 years behind adult devices. This means that for certain diseases, children have no device options, or have to rely on adult devices that are modified and used off-label with little or no safety data for their use in pediatrics. To address this gap, the US Food and Drug Administration (FDA) has developed a number of programmatic and regulatory initiatives, including creating the Pediatric Device Consortia (PDC) that funds CTIP.