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  1. FDA perspective.

    Article, Communication - En anglais

    International conference on circulatory support devices for severe cardiac failure. Pittsburgh PA USA, 1994/10/28.

    In this article, based on a presentation before The Society of Thoracic Surgeons, D. Bruce Burlington, MD, director of the United States Food and Drug Administration's Center for Devices and Radiological Health, describes the role of the Center in regulating medical devices.

    Doctor Burlington discusses issues concerning investigational device exemptions and development of protocols, marketing review for new products, the use of guidance by the agency in developing products, and humanitarian device provisions.

    He focuses this discussion on circulatory support devices and therapies for cardiac patients.

    Throughout the discussion, Dr Burlington encourages manufacturers of new devices to discuss their plans and protocols with the agency before beginning their studies.

    Mots-clés Pascal : Appareil, Assistance cardiocirculatoire, Développement, Protocole thérapeutique, Technologie, Etats Unis, Amérique du Nord, Amérique, Traitement, Homme, Réanimation cardiocirculatoire, Produit, Industrie

    Mots-clés Pascal anglais : Apparatus, Cardiocirculatory support, Development, Therapeutic protocol, Technology, United States, North America, America, Treatment, Human, Intensive cardiocirculatory care, Product, Industry

    Logo du centre Notice produite par :
    Inist-CNRS - Institut de l'Information Scientifique et Technique

    Cote : 96-0112781

    Code Inist : 002B27B01. Création : 199608.