FDA-approved neurologic devices intended for use in infants, children, and adolescents.
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 On July 24, 2003, the FDA Center for Devices and Radiologic Health released for public comment a draft guidance document entitled "Premarket Assessment of Pediatric Medical Devices," which included in its objectives, the types of information needed to provide reasonable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 The draft guidance document is also relevant to the types of information needed to promote the safe and effective development of neurologic devices.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.
Peña
Carlos
C
US Food and Drug Administration/CDRH/ODE, Division of General, Restorative, and Neurological Devices, 9200 Corporate Blvd., HFZ-410, Rockville, MD 20850, USA. clp@cdrh.fda.gov
Bowsher
Kristen
K
Samuels-Reid
Joy
J
D000293:Adolescent; D001921:Brain / Q000254:growth & development; D002557:Cerebrospinal Fluid Shunts / Q000009:adverse effects / Q000295:instrumentation*; D002648:Child; D002675:Child, Preschool; D003054:Cochlear Implants / Q000009:adverse effects; D046690:Deep Brain Stimulation / Q000009:adverse effects / Q000295:instrumentation*; D018795:Device Approval; D006801:Humans; D007223:Infant; D012308:Risk Management; D014481:United States; D014486:United States Food and Drug Administration