• DocumentCode
    3502615
  • Title

    FDA rules for the medical device engineer

  • Author

    Munzner, Robert F.

  • Author_Institution
    Center for Devices & Radiol. Health, US Food & Drug Adm., Silver Spring, MD, USA
  • fYear
    1988
  • fDate
    4-7 Nov 1988
  • Firstpage
    48
  • Lastpage
    49
  • Abstract
    Since enactment of the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act in 1976, the US Food and Drug Administration has implemented rules that impinge on the design and testing of virtually all medical devices. These rules are described. The availability of FDA staff for informal guidance is noted
  • Keywords
    biomedical engineering; FDA rules; Federal Food Drug and Cosmetic Act; Medical Device Amendments; US Food and Drug Administration; informal guidance; medical device engineer; Biomedical engineering; Data engineering; Design engineering; Drugs; Manufacturing; Medical diagnostic imaging; Medical tests; Silver; Springs; Testing;
  • fLanguage
    English
  • Publisher
    ieee
  • Conference_Titel
    Biomedical Engineering., Proceedings of a Special Symposium on Maturing Technologies and Emerging Horizons in
  • Conference_Location
    New Orleans, LA
  • Type

    conf

  • DOI
    10.1109/MTEHBE.1988.26391
  • Filename
    26391
    • Link To Document
    https://search.isc.ac/dl/search/defaultta.aspx?DTC=49&DC=3502615