FDA and Children’s National Hospital Join Forces to Advance Pediatric Device Innovation

Children’s National Hospital and the FDA have initiated a five-year collaboration to address challenges in developing medical devices for children and infants. The partnership will create regulatory science tools using de-identified clinical data, multimodal imaging, and machine learning to enhance the evaluation and testing of pediatric devices. Currently, there is a significant gap in high-risk devices specifically designed for pediatric use, resulting in off-label usage and safety concerns. The initiative seeks to close this gap by providing open-source resources, as the current lack of regulatory incentives for pediatric medical devices has hindered innovation in the field.

Opens on MedTech Dive