Sage Journals: Discover world-class research

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Research article

First published 2017-2

Clinical Evidence Supporting US Food and Drug Administration Premarket Approval of High-Risk Otolaryngologic Devices,2000-2014

Vinay K. Rathi, Bo Wang, Joseph S. Ross [...]

Otolaryngology–Head and Neck Surgery

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Research article

First published 2011-8

Branched Grafts for Thoracoabdominal Aneurysms: Off-Label Use of FDA-Approved Devices

Karthik Kasirajan

Journal of Endovascular Therapy

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Other

First published 1993-04

Fda Approval Is Shield Against Many Injury Suits Involving Medical Devices

Biotechnology Law Report

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Letter

First published 2012-2

RE: “Branched Grafts for Thoracoabdominal Aneurysms: Off-Label Use of FDA-Approved Devices”

Pierre Galvagni Silveira, Gilberto N. Galego, Cristiano T. Bortoluzzi [...]

Journal of Endovascular Therapy

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Letter

First published 2011-12

Re: “Branched Grafts for Thoracoabdominal Aneurysms: Off-Label Use of FDA-Approved Devices” by Dr. Karthik Kasirajan

Timothy A. M. Chuter, Roy K. Greenberg

Journal of Endovascular Therapy

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Research article

First published 1989-02

FDA Approves Clinical Trials on Excimer Laser Use in Ophthalmic Disorders Summit Technology Granted Investigational Device Exemption [IDE]

Carole Moussalli

Photobiomodulation,Photomedicine,and Laser Surgery

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Research article

First published 2006-7

Marketing Strategy: Coming to America: Guidelines and Suggestions for a European Medical Device Company Wishing to Enter the US Market

Leonard Nass, David P. Paul, Gwendolyn Y. Alexis [...]

Journal of Medical Marketing: Device,Diagnostic and Pharmaceutical Marketing

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Research article

First published 2012-10

Understanding Food and Drug Administration Regulatory Requirements for an Investigational Device Exemption for Sponsor-Investigators

M. E. Blair Holbein, Jelena Petrovic Berglund

Journal of Investigative Medicine

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Research article

First published 2008-5

Caveat Emptor: The Need for Evidence,Regulation,and Certification of Home Telehealth Systems for the Management of Chronic Conditions

Bonne Farberow, Valerie Hatton, Cindy Leenknecht [...]

American Journal of Medical Quality

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Research article

First published 2008-04

Supplemental Applications Proposing Labeling Changes for Approved Drugs,Biologics,and Medical Devices [excerpts]

Biotechnology Law Report

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