Regulation of medical devices in the United States and European Union

N Engl J Med. 2012 Mar 1;366(9):848-55. doi: 10.1056/NEJMhle1113918. Epub 2012 Feb 14.
No abstract available

Publication types

  • Comparative Study
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Device Approval / legislation & jurisprudence*
  • Device Approval / standards
  • European Union
  • Government Regulation*
  • Risk
  • United States
  • United States Food and Drug Administration