The Food and Drug Administration (FDA) ASK CHILDREN study is now available to allow for telephone interviews if a subject cannot attend an appointment in person.

FDA conducted a public workshop on September 13, 2010 entitled ASK (Assess Specific Kinds of CHILDREN Challenges for Neurologic Devices). The purpose of the public workshop was to solicit comments 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 public workshop provided an overview of pediatric initiatives across the Agency, neurological and neurosurgical perspectives on medical devices, a review of 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 established a science-based framework of recommendations to aid in the development of more efficient strategies in evaluating pediatric neuroprostheses regulated by the Agency. For more information, please refer to the meeting on the Internet at:

http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm222293.htm