• DocumentCode
    1476991
  • Title

    FDA Regulation of Invasive Neural Recording Electrodes: A Daunting Task for Medical Innovators

  • Author

    Welle, Cristin G. ; Krauthamer, Victor

  • Author_Institution
    Div. of Phys., FDA, Silver Spring, MD, USA
  • Volume
    3
  • Issue
    2
  • fYear
    2012
  • fDate
    3/1/2012 12:00:00 AM
  • Firstpage
    37
  • Lastpage
    41
  • Abstract
    In this paper, the basics of FDA regulatory premarket process were introduced that relates to chronically implanted recording devices in the central or peripheral nervous system.
  • Keywords
    ISO standards; biomedical electrodes; market research; neurophysiology; prosthetics; regulation; FDA regulatory premarket process; central nervous system; chronically implanted recording devices; invasive neural recording electrodes; market research; medical innovators; peripheral nervous system; Clinical trials; Commercialization; Drugs; ISO standards; Reliability; Testing; US Food and Drug Administration; Clinical Trials as Topic; Device Approval; Diagnostic Techniques, Neurological; Electrodes, Implanted; Equipment Safety; Humans; United States; United States Food and Drug Administration;
  • fLanguage
    English
  • Journal_Title
    Pulse, IEEE
  • Publisher
    ieee
  • ISSN
    2154-2287
  • Type

    jour

  • DOI
    10.1109/MPUL.2011.2181022
  • Filename
    6173096
    • Link To Document
    https://search.isc.ac/dl/search/defaultta.aspx?DTC=49&DC=1476991