The US Food and Drug Administration 515 Program Initiative: Addressing the Evidence Gap for Widely Used, High-Risk Cardiovascular Devices?

JAMA Cardiol. 2016 May 1;1(2):117-8. doi: 10.1001/jamacardio.2016.0002.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administrative Personnel / legislation & jurisprudence
  • Cardiology / instrumentation*
  • Cardiology / legislation & jurisprudence
  • Device Approval / legislation & jurisprudence*
  • Equipment Safety
  • Heart-Assist Devices / adverse effects
  • Heart-Assist Devices / statistics & numerical data
  • Humans
  • United States
  • United States Food and Drug Administration / legislation & jurisprudence*