Evidence strength in FDA premarket approval of cardiovascular devices

JAMA. 2010 Apr 28;303(16):1599-600; author reply 1600-1. doi: 10.1001/jama.2010.511.
No abstract available

Publication types

  • Comment
  • Letter

MeSH terms

  • Cardiovascular Diseases / therapy
  • Device Approval / standards*
  • Equipment and Supplies* / adverse effects
  • Equipment and Supplies* / classification
  • Randomized Controlled Trials as Topic
  • Risk
  • Uncertainty
  • United States
  • United States Food and Drug Administration