Ibrahim Nicole, Gillette Nicole, Patel Hetal, Peiris Vasum
Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD, USA.
Division of Circulatory Support, Structural and Vascular Devices, Office of Cardiovascular Devices, Office of Product Evaluation and Quality, Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, WO66-2110, Silver Spring, MD, 20993, USA.
Pediatr Cardiol. 2020 Mar;41(3):469-474. doi: 10.1007/s00246-020-02296-0. Epub 2020 Mar 20.
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.
儿科医疗设备的审批滞后于成人医疗设备。从历史上看，医疗设备很少专门为儿童设计，儿童使用的设备大多是借鉴成人或通用应用。虽然多种社会、经济和临床因素导致了这一现象，但监管程序仍是儿科设备开发和商业化的一个基本方面。美国食品药品监督管理局（FDA）的设备与放射健康中心（CDRH）已经确定了推进的计划和技术领域，以支持满足儿童和特殊人群公共卫生需求的创新。我们重点介绍四个有可能塑造儿科心脏病学未来的监管领域：CDRH早期可行性研究计划、3D打印或增材制造的进展、计算建模与模拟以及将真实世界证据用于监管应用。这些计划有可能影响设备开发的各个阶段，从早期构思、设计和原型制作到临床证据生成、监管审查，最终到商业化。这些计划的成功依赖于包括政府、监管机构、设备制造商、患者、支付方以及学术和专业团体协会在内的利益相关者协作社区。
