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U.S. Department of Health and Human Services

Medical Devices

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Public Workshop - ASK CHILDREN (Assess Specific Kinds of CHILDREN Challenges for Neurologic Devices) STUDY Workshop, September 13, 2010

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.

Date, Time and Location

This meeting was held September 13, 2010, beginning at 9:00 am at the following location:

Meeting Venue: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31, Conference Center, the Great Room, Silver Spring, M.D. 20993.

The meeting was not be videotaped or webcasted.

Agenda and Presentations

TimeTopic
9:00-9:05 AM Welcome
Jeff Shuren, Director, Center for Devices and Radiological Health (CDRH), FDA
9:05-9:15 AM Workshop Purpose and Questions
Kristen Bowsher, Expert Reviewer, Division Of Ophthalmic, Neurological, And Ear Nose And Throat Devices (DONED), CDRH, FDA
9:15-9:35 AM Pediatric Initiatives and Medical Devices
Joy Samuels-Reid, Chief Medical Officer, Division of Anesthesiology, General Hospital, Infection Control, & Dental Devices (DAGID), CDRH, FDA/td>
9:35-9:55 AM Overview of Medical Device Regulation
Malvina Eydelman, Director, DONED, CDRH, FDA
9:55-10:15 AM The ASK CHILDREN Study-Purpose, Goals, and Progress-to-date
Carlos Peña, Senior Science Policy Advisor, Office of the Commissioner (OC), FDA
10:15-10:30 AM Break
10:30-10:55 AM Clinical Perspectives on Pediatric Neurologic Devices
Neurosurgical Approaches to Medical Devices

Shenandoah Robinson, Rainbow Babies & Children’s Hospital, University Hospitals
10:55-11:20 AM Clinical Perspectives on Pediatric Neurologic Devices
Neurological Considerations

Phillip L. Pearl, Division Chief, Neurology, Children’s National Medical Center
11:20-12:00 PM ASK CHILDREN Study Perspectives
Neil Friedman, Staff Physician, Pediatric Neurology, Cleveland Clinic
John Chelonis, University of Arkansas for Medical Sciences-Arkansas Children's Hospital/National Center for Toxicological Research, FDA
12:00-12:30 PM Speakers & Invited Experts Panel Discussion
Moderators
Carlos Peña, Senior Science Policy Advisor, OC, FDA
Joy Samuels-Reid, Chief Medical Officer, DAGID, CDRH, FDA
12:30-1:30 PM Lunch-On Your Own
1:30-2:30 PM Open Public Hearing
2:30-2:40 PM Patient Perspective
Lauri Rush, Patient Representative
2:40-3:10 PM Advocacy Community Perspective
Charleene Frazier, National Spinal Cord Injury Association & United Spinal Association
Debra Nussbaum, Cochlear Implant Education Center, Clerc Center
3:10-3:25 AM Break
3:25-3:50 PM Science Perspectives-Invited Expert on Neurologic Devices Research and Development
P. Hunter Peckham, Cleveland Functional Electrical Stimulation Center
3:50-4:30 PM Speakers & Invited Experts Panel Discussion
Moderators
Victor Krauthamer, Director, Office of Science and Engineering Laboratories, CDRH, FDA
Kristen Bowsher, Expert Reviewer, DONED, CDRH, FDA
4:30-4:45 PM Workshop Conclusion & Next Steps
Carlos Peña, Senior Science Policy Advisor, OC, FDA
Joy Samuels-Reid, Chief Medical Officer, DAGID, CDRH, FDA
 Adjourn

Workshop Participants

  • Moderator: Carlos Peña, Office of the Chief Scientist, Office of the Commissioner, FDA
  • Co-Moderator: Kristen Bowsher, Division Of Ophthalmic, Neurological, And Ear Nose And Throat Devices, Center for Devices and Radiological Health, FDA
  • John Chelonis, University of Arkansas for Medical Sciences-Arkansas Children 's Hospital/National Center for Toxicological Research, FDA
  • Ann Costello, Division Of Ophthalmic, Neurological, And Ear Nose And Throat Devices, Center for Devices and Radiological Health, FDA
  • Malvina Eydelman, Director, Division Of Ophthalmic, Neurological, And Ear Nose And Throat Devices, Center for Devices and Radiological Health, FDA
  • Suzanne Fitzpatrick, Office of the Chief Scientist, Office of the Commissioner, FDA
  • Charleene Frazier, National Spinal Cord Injury Association & United Spinal Association
  • Neil Friedman, Cleveland Clinic
  • George Jallo, The Johns Hopkins Hospital
  • Victor Krauthamer, Director, Division of Physics, Office of Science and Engineering Laboratories, CDRH, FDA
  • Warren Marks, Cook Children 's Medical Center
  • Debra Nussbaum, Cochlear Implant Education Center, Clerc Center
  • Phillip L. Pearl, Children’s National Medical Center
  • P. Hunter Peckham, Cleveland Functional Electrical Stimulation Center
  • Shenandoah Robinson, Rainbow Babies & Children’s Hospital, University Hospitals
  • Lauri Rush, Patient Representative
  • Joy Samuels-Reid, Division of Anesthesiology, General Hospital, Infection Control, & Dental Devices, Center for Devices and Radiological Health, FDA
  • Jeff Shuren, Director, Center for Devices and Radiological Health, FDA
  • Ann Tilton, Louisiana State University Health and Sciences Center
  • Susan Waltzman, New York University

Bibliography

Workshop Federal Register Notice

Workshop Related Guidance

Workshop Related Publications

  • Pena et al., FDA-approved neurologic devices intended for use in infants, children, and adolescents. Neurology. 2004 Oct 12;63(7):1163-7.
  • Samuels-Reid et al., Device safety and effectiveness in the pediatric population: a US FDA perspective. Expert Rev Med Devices. 2009 Mar;6(2):131-5.

Workshop Related Weblinks

Meeting Summary and Transcript

Contact Us

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