• DocumentCode
    861799
  • Title

    FDA regulation of new devices-expedited review

  • Author

    Flannery, E.J.

  • Author_Institution
    Covington & Burling, Washington, DC, USA
  • Volume
    7
  • Issue
    2
  • fYear
    1988
  • fDate
    6/1/1988 12:00:00 AM
  • Firstpage
    88
  • Lastpage
    89
  • Abstract
    The expedited review and approval of new medical devices by the US Food and Drug Administration (FDA) is described within the context of ethical issues in the regulation of new technologies. Current statutory provisions governing approval of medical devices, and the way in which the FDA has implemented these provisions are examined. Administrative efforts by the FDA to increase both the quality and efficiency of the new-product review process are then discussed.<>
  • Keywords
    biomedical equipment; reviews; FDA regulation; US Food and Drug Administration; new medical devices; new-product review process; Clinical trials; Costs; Delay effects; Drugs; Europe; Humans; Paper technology; Pregnancy; Product safety; Public healthcare;
  • fLanguage
    English
  • Journal_Title
    Engineering in Medicine and Biology Magazine, IEEE
  • Publisher
    ieee
  • ISSN
    0739-5175
  • Type

    jour

  • DOI
    10.1109/51.1983
  • Filename
    1983
    • Link To Document
    https://search.isc.ac/dl/search/defaultta.aspx?DTC=49&DC=861799