title: A surgeon's perspective regarding the regulatory, compliance, and legal issues involved with physician-modified devices.
abstract: 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.
authors: Division of Vascular Surgery, Department of Surgery, University of Washington, Seattle, WA, USA. starnes@uw.edu
authors: Benjamin W
authors: BW
authors: Starnes
mesh_terms: D001014:Aortic Aneurysm / Q000601:surgery*; D001291:Attitude of Health Personnel; D001807:Blood Vessel Prosthesis / Q000592:standards; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000331:legislation & jurisprudence / Q000592:standards; D018795:Device Approval / Q000331:legislation & jurisprudence / Q000592:standards; D004059:Diffusion of Innovation; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation* / Q000331:legislation & jurisprudence / Q000592:standards; D019983:Guideline Adherence; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D016365:Liability, Legal; D061214:Patient Safety; D010465:Perception; D017410:Practice Guidelines as Topic; D011474:Prosthesis Design; D018570:Risk Assessment; D012307:Risk Factors; D015607:Stents / Q000592:standards; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence / Q000592:standards