• DocumentCode
    861858
  • Title

    Development of PMA guidance for ventricular assist devices and total artificial heart

  • Author

    Acharya, A.

  • Author_Institution
    Food & Drug Adm., Silver Spring, MD, USA
  • Volume
    7
  • Issue
    2
  • fYear
    1988
  • fDate
    6/1/1988 12:00:00 AM
  • Firstpage
    90
  • Lastpage
    91
  • Abstract
    The US Food and Drug Administration´s (FDA´s) involvement in the investigation of devices since 1980 is discussed. The development of draft guidelines for a premarket approval application (PMA) is described. The availability of the document is announced and comments are solicited.<>
  • Keywords
    artificial organs; cardiology; US Food and Drug Administration; premarket approval application; total artificial heart; ventricular assist devices; Animals; Artificial heart; Cardiology; Clinical trials; Drugs; Laboratories; Manufacturing; Materials testing; Safety devices; Surgery;
  • fLanguage
    English
  • Journal_Title
    Engineering in Medicine and Biology Magazine, IEEE
  • Publisher
    ieee
  • ISSN
    0739-5175
  • Type

    jour

  • DOI
    10.1109/51.1984
  • Filename
    1984
    • Link To Document
    https://search.isc.ac/dl/search/defaultta.aspx?DTC=49&DC=861858