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Safe Medical Devices for Children
cal devices. Furthermore, to the extent that public and professional trust in the FDA is affected by controversy over the agency’s monitoring of drug safety, it is appropriate to be concerned about a loss of public confidence in the agency’s performance in other arenas.
Much of the discussion in this report pertains to both children and adults because adequate regulatory safeguards for children require an effectively performing basic program for medical device regulation. Upon that foundation, resources and expertise focused on the special needs and characteristics of infants, children, and adolescents should be added. As described in Chapters 1 and 2, Congress recognized this in the Medical Device User Fee and Modernization Act of 2002 (P.L. 107–250), which directed FDA to develop guidance and other resources to strengthen the premarket assessment of medical devices used with children. The Center for Devices and Radiological Health (CDRH) has recently created a pediatric webpage, a useful step to encourage attention to pediatric concerns related to medical devices. Responding to further legislative directives in the Medical Devices Technical Corrections Act of 2004 (P.L. 108–214), the agency solicited views and prepared a report on barriers to and possible incentives for the development of devices to meet children’s special needs and characteristics (FDA, 2004y). Box 7.1 summarizes key points in that report.
Other legislation has also directed FDA attention to pediatric issues, mostly related to pharmaceuticals. Among a number of provisions related to children, the Best Pharmaceuticals for Children Act of 2002 (P.L. 107–109) directed FDA to create an Office of Pediatric Therapeutics to be responsible for coordinating and facilitating FDA activities that affect children and the practice of pediatrics. The Office was created in October 2002. The legislation also directed the creation of a Pediatric Advisory Committee to advise the FDA Commissioner on pediatric issues (see, FDA, 2003k). Although pediatric therapeutics includes the use of medical devices, the website for the Office of Pediatric Therapeutics focuses nearly exclusively on drugs.
Beyond the existing CDRH pediatric webpage and guidance documents, FDA should act to organize a central point of knowledge and coordination for pediatric issues within CDRH specifically. That focal point or unit would be responsible for evaluating the adequacy of the Center’s access to pediatric expertise and its attention to pediatric issues in all phases of the Center’s work, including premarket reviews, postmarket surveillance, device labeling related to pediatric use, and outreach to other public and private organizations and individuals concerned with children’s health and well-being. For example, to support families caring for a device-reliant child in the community, the unit could work with the Center’s home health committee to develop easier and more accessible adverse event reporting opportunities and more resources on safe device use as recommended in