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

Judah Weinberger, John H. Rundback, Elizabeth V. Ratchford

Research output: Contribution to journalArticlepeer-review

Abstract

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 pathways for obtaining such approval for endovascular devices used in the treatment of peripheral arterial disease. Unique issues pertinent to clinical trials carried out in this area are highlighted. Future directions for evolution of the regulatory process consonant with the mandated requirements for demonstration of safety and efficacy are discussed.

Original languageEnglish (US)
Pages (from-to)186-191
Number of pages6
JournalAmerican Journal of Therapeutics
Volume12
Issue number2
DOIs
StatePublished - Mar 1 2005
Externally publishedYes

Keywords

  • Devices
  • Endovascular
  • FDA
  • Peripheral vascular disease
  • Regulatory approval

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

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