Center for Devices & Radiological Health, US Food & Drug Administration, 10903 New Hampshire Ave WO 66 - 2608, Silver Spring, MD, 20993 USA.
Expert Rev Med Devices. 2014 Mar;11(2):169-74. doi: 10.1586/17434440.2014.864234. Epub 2014 Jan 6.
There are many barriers to the availability of medical devices intended for the pediatric population causing healthcare providers to use creative measures to address pediatric unmet device needs. The USA has taken significant legislative measures to spur medical device development and address the unmet needs in all pediatric subpopulations. For example, the Medical Device User Fee and Modernization Act of 2002 amended the Federal Food Drug and Cosmetic Act by adding new provisions intended to promote the development of safe and effective pediatric devices, and to protect the pediatric population during clinical trials. In 2004, the Medical Devices Technical Corrections Act was added to address potential difficulties in bringing pediatric devices to the market. Further, the Pediatric Medical Device Safety and Improvement Act of 2007 and the Food and Drug Administration Amendments Act of 2007 provided the FDA significant new responsibilities and authorities regarding pediatric use.
有许多障碍阻碍了儿科人群使用的医疗器械的供应，这导致医疗保健提供者不得不采取创造性措施来满足儿科未满足的器械需求。美国已经采取了重大的立法措施来刺激医疗器械的发展，并解决所有儿科亚人群的未满足需求。例如，2002 年的《医疗器械用户收费和现代化法案》修订了《联邦食品、药品和化妆品法案》，增加了新的条款，旨在促进安全有效的儿科器械的发展，并在临床试验期间保护儿科人群。2004 年，《医疗器械技术修正法案》被添加进来，以解决将儿科器械推向市场的潜在困难。此外，2007 年的《儿科医疗器械安全与改进法案》和 2007 年的《食品和药物管理局修正案》为 FDA 提供了关于儿科使用的重要新职责和权力。
