Regulatory Science, and How Device Regulation Will Shape Our Future

Volume: 41, Issue: 3, Pages: 469 - 474
Published: Mar 1, 2020
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...
Paper Details
Title
Regulatory Science, and How Device Regulation Will Shape Our Future
Published Date
Mar 1, 2020
Volume
41
Issue
3
Pages
469 - 474
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