Publication date: Mar 20, 2020
Pediatric medical device approvals lag behind adult approvals. Historically, medical devices have rarely been designed specifically for children, but use in children has most often borrowed from adult or general use applications. While a variety of social, economic, and clinical factors have contributed to this phenomenon, the regulatory process remains a fundamental aspect of pediatric device development and commercialization. FDA’s Center for Devices and Radiological Health (CDRH) has established programmatic and technological areas of advancement to support innovation that serves the public health needs of children and special populations. We highlight four regulatory areas that have the potential to shape the future of pediatric cardiology: the CDRH Early Feasibility Study Program, advancements in 3D printing or additive manufacturing, computational modeling and simulation, and the use of real-world evidence for regulatory applications. These programs have the potential to impact all stages of device development, from early conception, design, and prototyping to clinical evidence generation, regulatory review, and finally commercialization. The success of these programs relies on a collaborative community of stakeholders, including government, regulators, device manufacturers, patients, payers, and the academic and professional community societies.
Ibrahim, N., Gillette, N., Patel, H., and , Peiris. Regulatory Science, and How Device Regulation Will Shape Our Future. 06549. 2020 Pediatr Cardiol.
|Computational Modeling||Additive manufacturing|
- The ‘Digital Twin’ to enable the vision of precision cardiology.
- Integrated Platform Drug Discovery and Development Companies – Part 1
- 3D Printing of Pharmaceuticals and Drug Delivery Devices.
- Operational strategies in US cancer centers of excellence that support the successful accrual of racial and ethnic minorities in clinical trials.
- A Feasibility Study of an Extrusion-Based Fabrication Process for Personalized Drugs.
- Systems Pharmacology – When multi-targeting is advantageous (Part 1 of 2)