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Regulatory Science, and How Device Regulation Will Shape Our Future

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Abstract

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.

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Authors and Affiliations

  1. Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD, USA

    Nicole Ibrahim, Nicole Gillette, Hetal Patel & Vasum Peiris

  2. 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

    Nicole Ibrahim

Authors
  1. Nicole Ibrahim
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  2. Nicole Gillette
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  3. Hetal Patel
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  4. Vasum Peiris
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Correspondence to Nicole Ibrahim.

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Ibrahim, N., Gillette, N., Patel, H. et al. Regulatory Science, and How Device Regulation Will Shape Our Future. Pediatr Cardiol 41, 469–474 (2020). https://doi.org/10.1007/s00246-020-02296-0

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