• DocumentCode
    862019
  • Title

    Ethical issues in the regulation and development of engineering achievements in medical technology-a regulatory perspective

  • Author

    Rahmoeller, G.A.

  • Author_Institution
    Biometric Res. Inst. Inc., Arlington, VA, USA
  • Volume
    7
  • Issue
    2
  • fYear
    1988
  • fDate
    6/1/1988 12:00:00 AM
  • Firstpage
    94
  • Lastpage
    95
  • Abstract
    A description is given of the ethical issues encountered by the US Food and Drug Administration (FDA) in its regulation of new life-saving devices. Issues related both to clinical investigation and to marketing approval of the devices are examined. The potential role of engineers in addressing these issues is discussed.<>
  • Keywords
    biomedical engineering; reviews; US Food and Drug Administration; clinical investigation; life-saving devices; marketing approval; Biomedical engineering; Biometrics; Control systems; Drugs; Heart valves; Medical control systems; Medical treatment; Pharmaceutical technology; Prosthetics;
  • fLanguage
    English
  • Journal_Title
    Engineering in Medicine and Biology Magazine, IEEE
  • Publisher
    ieee
  • ISSN
    0739-5175
  • Type

    jour

  • DOI
    10.1109/51.1986
  • Filename
    1986
    • Link To Document
    https://search.isc.ac/dl/search/defaultta.aspx?DTC=49&DC=862019