FDA's Pediatric Device Consortia: National Program Fosters Pediatric Medical Device Development
FDA's Pediatric Device Consortia: National Program Fosters Pediatric Medical Device Development
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DOI：
10.1542/peds.2012-1534
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发表时间：
2013-05-01
期刊：
影响因子：
8
通讯作者：
Koenig, Robert L.
中科院分区：
文献类型：
--
作者：
Ulrich, Linda C.;Joseph, Francesca D.;Koenig, Robert L.
目的：本文报告了通过建立儿科器械联盟赠款计划，在满足儿科医疗器械需求方面取得的进展。儿科从业者应该意识到对儿童设备进行充分研究的必要性，以及最近创建的帮助促进此类产品开发的资源的存在。方法：本文讨论了与儿科设备开发相关的一些挑战，并描述了2007年《儿科医疗设备安全和改进法案》第305节的实施情况。该法规呼吁建立非营利性联合体，以促进儿科医疗器械的开发、生产和分销。结果：总结了儿科器械联合体的成就。自2009年以来，已向5个财团发放了1100万美元的奖金。截至2012年7月，他们已共同协助开发了219个儿科设备创意。该联盟为创新者提供指导和服务，以帮助推进拟议的儿科器械项目，包括协助制作原型、确定潜在的资金来源、临床前和临床试验设计，以及介绍潜在的制造商。结论：目前，有5个联邦资助的儿科器械联合体帮助推进潜在的儿科器械的开发。这些联盟为那些对医疗设备有想法的人提供了国家资源，这些设备可能会促进儿童的健康和福祉。
OBJECTIVES: This article reports on the progress made in addressing pediatric medical device needs through the establishment of the Pediatric Device Consortia Grant Program. Pediatric practitioners should be aware of both the imperative for well-studied devices for children and the existence of recently created resources to help foster the development of such products.METHODS: This article discusses some of the challenges associated with pediatric device development and describes the implementation of section 305 of the Pediatric Medical Device Safety and Improvement Act of 2007. This statute called for the creation of nonprofit consortia to facilitate the development, production, and distribution of pediatric medical devices.RESULTS: A summary of the accomplishments of the pediatric device consortia is presented. Eleven million dollars have been awarded to 5 consortia since 2009. As of July 2012, they have collectively assisted in the development of 219 pediatric device ideas. The consortia provide innovators with both mentorship and services to help advance proposed pediatric device projects, including assistance with prototyping, identification of potential funding sources, preclinical and clinical trial design, and introductions to potential manufacturers.CONCLUSIONS: Currently, 5 federally funded pediatric device consortia exist to help advance the development of potential pediatric devices. These consortia serve as a national resource for those with ideas for medical devices that may advance the health and well-being of children.