Regulatory approval of peripheral endovascular revascularization devices in the United States: is the horse still in the barn?

@article{Weinberger2005RegulatoryAO,
  title={Regulatory approval of peripheral endovascular revascularization devices in the United States: is the horse still in the barn?},
  author={Judah Weinberger and John H. Rundback and Elizabeth V. Ratchford},
  journal={American journal of therapeutics},
  year={2005},
  volume={12 2},
  pages={186-91}
}
The regulatory processes by which industry obtains approval for marketing and sales of medical devices from the United States Food and Drug Administration is distinct from the drug approval pathways, poorly understood by clinicians, and widely criticized by clinical investigators and industrial sponsors of new technology. This paper reviews the most common… CONTINUE READING