Sage Journals: Discover world-class research

Retricted access

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 2014-6

Recommendations from the Investigational New Drug/Investigational Device Exemption Task Force of the Clinical and Translational Science Award Consortium: Developing and Implementing a Sponsor-Investigators Training Program

M. E. Blair Holbein, Jelena Petrovic Berglund, Erin K. O'Reilly [...]

Journal of Investigative Medicine

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Editorial

First published 2005-10

Initial Application for Investigational Device Exemption (IDE)

E. Soriano

The Neuroradiology Journal

Open access

Research article

First published 2021-1

Efficacy and safety associated with the use of the Surfacer ® Inside-Out ® Access Catheter System: Results from a prospective,multicenter Food and Drug Administration–approved Investigational Device Exemption study

Mahmood K Razavi, Eric K Peden, Ehab Sorial [...]

The Journal of Vascular Access

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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

Free access

Abstract

First published 2016-4

Safety and Efficacy of i-FACTORTM Bone Graft in Anterior Cervical Discectomy and Fusion: A Prospective,Randomized,Controlled,Multi-Center,Investigational Device Exemption Study

Michael Janssen, Paul Arnold, Rick Sasso [...]

Global Spine Journal

Free access

Review article

First published 2012-6

Cervical Total Disc Arthroplasty

Rahul Basho, Kenneth A. Hood

Global Spine Journal

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Research article

First published 2015-10

The Food and Drug Administration and pragmatic clinical trials of marketed medical products

Monique L Anderson, Joseph Griffin, Sara F Goldkind [...]

Clinical Trials

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Research article

First published 2020-3

The Perils of Parity: Should Citizen Science and Traditional Research Follow the Same Ethical and Privacy Principles?

Barbara J. Evans

The Journal of Law,Medicine & Ethics

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Research article

First published 2005-09

Multi-institutional Pivotal Trial of the Zenith TX2 Thoracic Aortic Stent-Graft for Treatment of Descending Thoracic Aortic Aneurysms: Clinical Study Design

Heitham T. Hassoun, Michael D. Dake, Lars G. Svensson [...]

Perspectives in Vascular Surgery and Endovascular Therapy

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