A surgeon's perspective regarding the regulatory, compliance, and legal issues involved with physician-modified devices

摘要

Physician-modified endovascular devices are becoming commonplace in a modern climate where innovation outpaces regulated technological advancement. Off-label use of medical devices occurs on a daily basis throughout many institutions across the United States and when performed by physicians, is both legal and unregulated. The purpose of this invited commentary is to review the regulatory, compliance, and legal issues regarding the practice of medical device modification. ? 2013 Society for Vascular Surgery.