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The Food and Drug Administration (FDA) is announcing a public Workshop to solicit information from academic investigators and clinicians associated with the use, research and/or development of pediatric neuroprostheses regarding approaches for enhancing the protection and promotion of public health in children and adolescents with neuroprostheses.

The purpose of the workshop is to provide an overview of pediatric initiatives across the Agency, neurological and neurosurgical perspectives on medical devices, pediatric assessments and outcome measures, and scientific research issues associated with the use of neuroprotheses in pediatric populations, including cochlear implants, deep brain stimulators, hydrocephalus shunts, spinal cord stimulators, and vagus nerve stimulators. Information from this public workshop will aid in the development of more efficient strategies in evaluating pediatric neuroprostheses regulated by the Agency.

Carlos Peña, Ph.D.

Food and Drug Administration

10903 New Hampshire Avenue, WO32-4264

Silver Spring, MD

20993-0002

Phone: 301-796-8521

FAX: 301-847-8617

Email: carlos.pena@fda.hhs.gov

    

SOURCE

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