• DocumentCode
    2749329
  • Title

    Getting your medical device cleared for marketing in the US

  • Author

    Bartoo, Grace ; Munzner, Robert F.

  • Volume
    2
  • fYear
    2004
  • fDate
    1-5 Sept. 2004
  • Firstpage
    5136
  • Abstract
    Summary form only given. This discussion group will explore the different requirements for getting a medical device cleared for marketing in the United States. Specifically, the discussion leaders will give an overview of the 510(k) and PMA, registration, and listing processes. The discussion will also include what is required for foreign companies who wish to import medical devices.
  • Keywords
    biomedical equipment; marketing; reviews; United States; marketing; medical device; overview; 510(k); FDA; Medical device; PMA; industry;
  • fLanguage
    English
  • Publisher
    ieee
  • Conference_Titel
    Engineering in Medicine and Biology Society, 2004. IEMBS '04. 26th Annual International Conference of the IEEE
  • Conference_Location
    San Francisco, CA
  • Print_ISBN
    0-7803-8439-3
  • Type

    conf

  • DOI
    10.1109/IEMBS.2004.1404426
  • Filename
    1404426