Journal of Long-Term Effects of Medical Implants

ISSN for PRINT: 1050-6934

For Online Access

Best Paper Award Selection - Editorial Board Site

2007, Volume17

Issue 2

119 pages

Issue price - $189.00

Paula J. McKay
Department of Surgery, McMaster University, Hamilton, Ontario, Canada

Sarah Resendes
Department of Surgery, McMaster University, Hamilton, Ontario, Canada

Emil Schemitsch
University of Toronto, Toronto, Ontario, Canada

Mohit Bhandari
Division of Orthopaedic Trauma, Hamilton Health Sciences, General Hospital Site, 237 Barton Street East, Hamilton, Ontario L8L 2X2 Canada

Regulatory trials allow for the clinical evaluation of new drugs and medical devices, determining whether or not they can be safely and effectively used in patient care. The outcome of these trials may result in new and better ways of preventing, diagnosing, and treating illness. However, conducting a regulatory trial to evaluate a new medical device is a complex and time-intensive process involving many parties. This paper will provide an overview of the regulatory approval process for medical devices in the United States and will discuss what is involved in conducting a regulatory trial investigating a new device.

Download article, 165-171 pages

Article price - $35.00

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