• J. Vasc. Surg. · Mar 2013

    Review

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

    • Benjamin W Starnes.
    • Division of Vascular Surgery, Department of Surgery, University of Washington, Seattle, WA, USA. starnes@uw.edu
    • J. Vasc. Surg. 2013 Mar 1; 57 (3): 829-31.

    AbstractPhysician-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.Copyright © 2013 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.

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