Key result
A review of FDA-approved neurologic devices for children highlights considerations for minimizing risks associated with brain development, physical growth, surgery, and human factors.
This review highlights the FDA's draft guidance on pediatric medical devices and discusses risk assessment and mitigation for neurologic devices in children.
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Pediatric indications appear in nearly half of approved high-risk neurologic devices; leaves open standardized premarket assessment criteria for children.
The US Food and Drug Administration (FDA) has approved several applications for the marketing of neurologic devices. Nineteen high risk Class III medical devices were approved for the central and peripheral nervous system for marketing between 1994 and 2003, and almost half (n = 8) include indications for use in children as well as adults. On July 24, 2003, the FDA Center for Devices and Radiologic Health released for public comment a draft guidance document entitled "Premarket Assessment of Pediatric Medical Devices," which included in its objectives, the types of information needed to provide reasonable assurance of the safety and effectiveness of medical devices intended for use in children. The draft guidance document is also relevant to the types of information needed to promote the safe and effective development of neurologic devices. We review risk assessment and ways to reduce risk for neurologic devices intended for use in children. We also discuss the deep brain stimulator, the cochlear implant, and the CSF shunt, and considerations for minimizing risks associated with brain development, physical growth, surgery, and human factors.
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Peña et al. (2004) conducted a review in Neurologic conditions requiring devices. Neurologic devices (deep brain stimulator, cochlear implant, CSF shunt) was evaluated. A review of FDA-approved neurologic devices for children highlights considerations for minimizing risks associated with brain development, physical growth, surgery, and human factors.
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