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The Challenges of Clinical Validation of Emerging Technologies: Computer-Assisted Devices for Surgery

Janda, Michel, MS1; Buch, Barbara, MD1

doi: 10.2106/JBJS.H.01337
Section I: Setting the Stage
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Over the last decade, the use of computers and robotics in medicine has increased commensurate with emergent advances in technology. This article largely focuses on the challenges that the U.S. Food and Drug Administration faces when evaluating new technologies for entry into the market. How different categories of devices are categorized and what types of data have been used for regulatory approval or clearance are described. These are compared with expectations that the clinical community may have for these devices. A brief discussion of current regulatory thinking about these types of devices is also included.

1Division of General Restorative and Neurological Devices, Center for Devices and Radiologic Health, U.S. Food and Drug Administration, 9200 Corporate Boulevard, HFZ-410, Rockville, MD 20850

Copyright © 2009 by The Journal of Bone and Joint Surgery, Incorporated
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