Department of Health and Human Services August 20, 2010 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing a public workshop entitled ASK (Assess Specific Kinds of CHILDREN Challenges for Neurologic Devices) Study Children Workshop. The purpose of the public workshop is 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 will provide 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 will help establish a science-based framework of recommendations to aid in the development of more efficient strategies in evaluating pediatric neuroprostheses regulated by the Agency.

This final notice announces our decision to approve without condition the American Association for Accreditation of Ambulatory Surgery Facilities' (AAAASF) request for continued recognition as a national accreditation program for ambulatory surgical centers (ASC) seeking to participate in the Medicare or Medicaid programs.